22 jobs found in lakewood township

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview Perform activities including, but are not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance. This is a 2nd shift position Responsibilities • Perform Line change over, set-up, start-up, including vision system training and data collection • Identify parts needed for repairs using parts manual for specific equipment and will assemble requisition for supervisor to order parts. • Responsible for on-going preventative maintenance of machinery or equipment • Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines. • Maintain, repair and troubleshoot electronics on all production equipment on the sterile filling and packaging lines to minimize production downtime. • Use computer and logic controllers to perform system analysis of equipment. • Troubleshoot and repairs logic controls/PLC, steam regulators, steam traps, steam strainers, steam valves, temperature control loops associated with autoclaves, tunnels, ovens. • Troubleshoot vision systems and automated weight checkers • Fabricate and install simple control systems to enhance line performance. • Perform changeover of packaging line equipment from one size and product to another accurately documenting the activities in accordance with procedures. • Ability to be a team player; works cooperatively with others to solve problems and proactively helps others when assistance is needed. • Experience in FDA regulated environment • Shift flexibility per business needs, and willingness to work overtime • Demonstrated ability to be flexible and open to change, self-directed, motivated, and task oriented • Make effective decisions and take action based on deductive reasoning and potential product impact. • Identify improvement opportunities in given processes / procedures • Possess strong team skills with the ability to promote clear and thorough communication both written and oral as well as through electronic means. • Must be able to be gowned qualified and maintain gowning status Qualifications High school degree, with a Minimum of 5 years of relevant mechanical experience; or equivalent combination of advanced education and experience. Experience in an aseptic/pharmaceutical packaging environment preferred. PI119445692

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Project Engineer is responsible for managing construction and engineering projects in a cGMP environment through planning, organizing and controlling all elements of the project. Have the ability and competency to oversee all facility and utility upgrade projects. Apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. Ability to work in a fast-pace environment and the competence to concurrently handle multiple projects and operational initiatives. Responsibilities • Manage small, medium to large projects from requirement specifications & design to implementation and validation phases • Drive and ensure compliance with all federal and state regulations, including OSHA, DEP, EPA, FDA. • Create detailed project plans and schedules using MS Project to drive successful project outcome, while driving accountability. • Prepare project support documentation, including: project scopes, presentation of conceptual designs, capital requests, purchase orders, project plans and schedules using MS Project to drive successful project outcome, user/functional specifications, design specifications, piping and instrumentation diagrams, process flow diagrams, start-up and equipment operational procedures and commissioning. • Control project cost by ensuring robust contractor agreements are in place, prior to commencing any work, and by closely monitoring and approving capital expenditures. • Prepare and review contractor bids, interviews and vendor selection. • Ensure appropriate communication to all project stakeholders through meetings, project reports, and other forms of communication. • Design and specify HVAC systems and other utility solutions (WFI Water, Compressed Air, Vacuum, Clean Steam, Nitrogen, etc.) in support of manufacturing, packaging and laboratory spaces. • Knowledge of cGMP manufacturing space construction in compliance with ISO 14644 Cleanroom standards. • Knowledge of Building Management Systems and Computerized Maintenance Management Systems. • Perform design review for all construction related designs: mechanical, electrical and plumbing. • Assist in the design review, factory acceptance, site acceptance, installation of equipment, as well as equipment qualification • Evaluate equipment performance and provide improvement recommendation for equipment optimization, while ensure safe operation. • Support compliance activities, such as change control, deviation management and CAPA resolution • Assist in investigations of facility equipment, utility systems, and control anomalies as well as safety incidents. • Write and modify procedures for the proper operation of new and/or existing equipment. • Propose and implement operational efficiency improvements for facility and utility systems. • Assist with training of operations and maintenance personnel, as needed. • Perform other duties and responsibilities as assigned. Qualifications B.S. degree in Mechanical, Electrical Engineering is required. 3 to 7 years of relevant experience in the pharmaceutical industry and PMP certification is a plus. Must possess: • A thorough knowledge of construction in a cGMP environment, HVAC design and controls requirements. • Advanced knowledge of engineering documentation required for cGMP processing and substantial knowledge of cleanroom design and operation. • Extensive knowledge of project management, utilizing PMO standards PI119445694

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Laboratory Information System Administrator (admin) has in depth knowledge of internal business processes and systems. That knowledge is leveraged to improve, assist and direct others with their operational requirements as it relates to all standalone and networked laboratory systems. The admin is also an organized, clear thinking problem solver. Using various available tools to analyze data, resolve issues and offer methods to improve and streamline internal processes. Knowledge of SQL (Structured Query Language) as well as the ability to present and report information obtained from various databases is required. Reviews all lab system designs and integration of systems, i.e. ERP-LN, provides backup recovery and makes recommendations regarding enhancements and/or improvements. Maintains security and integrity controls. Formulates procedures relating to database management. The ability to accomplish multiple tasks in a rapidly changing environment is essential as well as the requirement to manage larger scale projects / upgrades. Corporate wide interaction with all levels of management and departments is crucial. Direct liaison with vendors for ongoing software updates as well as licensing contracts. Responsibilities • Responsible for day to day support of all lab systems for Lakewood site • Provide IT Help Desk solutions where necessary for all lab systems in a timely manner. • Manage all updates to the lab system and write the functional specifications for all future enhancements to the system. • Act as the liaison between Renaissance and vendors when it comes to issue escalation, updates, and upgrades. • Keep detailed track of all code updates and keep the test and production environments in sync. • Preform other IT duties that may be assigned over time, to assist in the possible maintaining of other lab systems. • Manage LIMs environment, LIMs user management, issue resolution, system setup and backup, user training and other related LIMs activities. • Prepare and maintain IT SOPs for LIMs for Lakewood site. • Develop and define technical solutions to business problems along with analyzing and documenting specifics. • The LIMs admin is responsible for creating and reviewing business processes, identifying and addressing operational functionality of the LIMs. Identify opportunities to improve efficiency workflows within the corporate environment. • SSRS (SQL Server Reporting Services) and Crystal Reports coding required for backend data analysis. • Strong knowledge of Microsoft Excel, Word, Visio, PowerPoint and Project. • Strong understanding of Empower5. • Initiate and write Trackwise change controls when applicable for changes to the lab systems. Qualifications Bachelor's degree with a minimum of 5 years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience, strong knowledge of Empower 5 and other lab systems. PI119423695

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The IT Compliance and Validation Supervisor is position is responsible for leading a team that is tasked with supporting the design, installation, implementation and validation of electronic systems to meet all applicable industry standards and regulatory requirements. The successful candidate will act as an advisor to the Director of IT in all areas of system compliance and validation and must have the ability to raise issues that they see as risk to the company. This position frequently interacts with customers and other groups at the Site and coordinates the IT validation tasks. Responsibilities • Guides the work efforts of direct reports, and mentors them in all areas of compliance and validation. • Responsible for initiating/maintaining the IT Master Inventory of Electronic Systems. • Prepare gap assessments, user requirements, functional and configuration specifications, traceability matrix, test scripts, validation plans, IQ, OQ, PQ and summary reports. Other validation documentation as needed. • Gather, understand and document business objective. • Coordination of testing activities within the team, report progress of testing and significance of unfavorable results. • Create, support and provide input into system administration and standard operating procedures (SOPs) to ensure adequate controls for maintaining the validated state. • Coordinate and execute the training of Subject Matter Experts of electronic systems. • Make recommendations for improvements in laboratory productivity and quality of data. • Initiate and implement change control activities in accordance with current procedures • Work with IT leadership and business units to enhance existing procedures to further the efficiencies of compliance execution. • Other tasks as assigned. Qualifications Bachelor's degree or Associates Degree in Computer Science, Chemistry, Engineering or similar degree required, along with related business experience and a proven record of achievement. A minimum of 5 years of relevant experience in the pharmaceutical industry is required, including at least 2 years' experience supporting compliant IT systems. Must have a strong understanding of 21 CFR Part 11 code. Must be able speak to all levels of the organization regarding questions or concerns around compliance issues. PI119423697

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Process Mechanic- Electromechanical will perform activities including, but are not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance. This is a 3rd shift position. Responsibilities • Perform Line change over, set-up, start-up, including vision system training and data collection • Identify parts needed for repairs using parts manual for specific equipment and will assemble requisition for supervisor to order parts. • Responsible for on-going preventative maintenance of machinery or equipment • Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines. • Maintain, repair and troubleshoot electronics on all production equipment on the sterile filling and packaging lines to minimize production downtime. • Use computer and logic controllers to perform system analysis of equipment. • Troubleshoot and repairs logic controls/PLC, steam regulators, steam traps, steam strainers, steam valves, temperature control loops associated with autoclaves, tunnels, ovens. • Troubleshoot vision systems and automated weight checkers • Fabricate and install simple control systems to enhance line performance. • Perform changeover of packaging line equipment from one size and product to another accurately documenting the activities in accordance with procedures. • Ability to be a team player; works cooperatively with others to solve problems and proactively helps others when assistance is needed. • Experience in FDA regulated environment • Shift flexibility per business needs, and willingness to work overtime • Demonstrated ability to be flexible and open to change, self-directed, motivated, and task oriented • Make effective decisions and take action based on deductive reasoning and potential product impact. • Identify improvement opportunities in given processes / procedures • Possess strong team skills with the ability to promote clear and thorough communication both written and oral as well as through electronic means. • Must be able to be gowned qualified and maintain gowning status Qualifications High school degree, with a Minimum of 5 years of relevant mechanical experience; or equivalent combination of advanced education and experience. Experience in an aseptic/pharmaceutical packaging environment preferred. PI119423693

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview This is an entry level position to the Compounding Department with emphasis on ensuring that equipment used to process aseptic and non-aseptic products has been cleaned, sanitized or sterilized, as required by specific documentation or procedures. This entails performing automated and manual equipment cleaning prior to sterilization, placing cleaned equipment into autoclaves, starting and monitoring autoclaves, unloading equipment from autoclaves, and delivering equipment to areas of use. Perform Clean-In-place (CIP) and Steam-In-Place (SIP) functions as required by specific documentation or procedures. Maintain work area and equipment on a daily basis to ensure compliance. Work area is maintained at level to sustain organization of supplies and equipment. Area is kept clean and sanitized as required by current and applicable procedures. Equipment is kept in an organized and compliant manor. Introduction to compounding functions as deemed necessary by operations management and functions where qualified to perform. Responsibilities Follow manufacturing procedures specific to the task being performed. Support to compounding functions as deemed necessary by operations management and functions where qualified to perform. Support may include active batching functions. Operation of processing equipment, and the execution of manual and automated cleaning, sanitizing, and sterilization of tanks and equipment. Perform integrity testing of filters using automated filter integrity test equipment. Able to follow detailed diagrams and written instructions to assemble or disassemble equipment, configure equipment to be washed, configure equipment to be autoclaved. Show progression in competency in all aspects of the position. Demonstrate aptitude and capability to perform multiple tasks at the same time. Able to successfully pass sterile gowning qualification within a 1 month time limit. Perform environmental monitoring at grade level C and D room classifications Utilize knowledge to actively demonstrate process trouble-shooting capabilities whenever possible. Ability to maneuver drums and equipment in excess of 50 lbs and the capability to lift weights up to 50 lbs. Maintain accurate and complete documentation in fulfillment of all duties. Understand and comply with current SOP and GMP requirements relevant to the position. Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions. Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment. Assist supervisors and process manager in all other duties as assigned. Proper use of personal protective equipment at all times is required. Perform routine maintenance on process equipment. Perform area cleaning to maintain compliance using phenolic cleaners and sporicidal agent. A full face respirator or PAPR will be required to be worn for this position. Review MBRs throughout process to assure compliance to good documentation practices. Be available for unscheduled and scheduled overtime throughout the work week and weekend when requested. Qualifications A minimum of 1-3 years of relevant experience in the pharmaceutical industry; laboratory experience at the secondary education level. Aseptic manufacturing experience preferred. PI119423689

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Facilities MEP Engineer will ensure the continued efficient operation of the Lakewood site by providing service and support to the utility systems, existing equipment and all Facility related projects. This position is exempt from overtime. Responsibilities • Responsible for understanding and continuous improvement of existing plant utilities and management of equipment life expectancies. • Troubleshooting and resolving facility issues related to Grade A-D clean room design including temperature, relative humidity, differential pressure, or particulate recovery issues • Will oversee execution and management of Facility related projects such as modification/construction of new offices, laboratories, and other facility support areas. • Management of subcontractors utilized for Facility projects • Responsible for coordination of office moves, security/fire system modifications, parking management and landscaping changes. • Support of EHS initiatives and implementation of any resulting facility improvements required • Will interface with internal departments including, but not limited to, Operations, Human Resources, R&D, and Quality to meet their facility requirements. • Responsible for general facility upkeep and implementing improvements. • Other duties as assigned. Qualifications B.S. degree in Civil or Mechanical Engineering combined with a minimum of 5-7 years of relevant experience in the pharmaceutical or another FDA regulated industry preferred. PI119423690

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Compounder's primary responsibility is for the execution of bulk product batch processing, inclusive of all process related and administrative activities, as well as Equipment Preparation activities as declared in Compounder 1. Responsibilities Follow manufacturing procedures to process bulk product. Batches to be made right the first time. Follow manufacturing procedures specific to the task being performed. Perform compounding functions as deemed necessary by operations management and functions where qualified to perform. Operation of processing equipment, and the execution of manual and automated cleaning, sanitizing, and sterilization of tanks and equipment. Perform integrity testing of filters using automated filter integrity test equipment. Able to follow detailed diagrams and written instructions to assemble or disassemble equipment, configure equipment to be washed, configure equipment to be autoclaved. Show progression in competency in all aspects of the position. Demonstrate aptitude and capability to perform multiple tasks at the same time. Able to successfully pass sterile gowning qualification within a 1 month time limit. Aptitude to perform EM monitoring and testing of grade C and D clean rooms Utilize knowledge to actively demonstrate process trouble-shooting capabilities whenever possible. Ability to maneuver drums and equipment in excess of 50 lbs and the capability to lift weights up to 50 lbs. Maintain accurate and complete documentation in fulfillment of all duties. Understand and comply with current SOP and GMP requirements relevant to the position. Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions. Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment. Assist supervisors and process manager in all other duties as assigned. Proper use of personal protective equipment at all times is required. Perform routine maintenance on process equipment. Perform area cleaning to maintain compliance using phenolic cleaners and sporicidal agent. A full face respirator or PAPR will be required to be worn for this position. Review MBRs throughout process to assure compliance to good documentation practices. Qualifications EDUCATION: High school diploma or general education degree (GED) required. EXPERIENCE: A minimum of 1-3 years of relevant experience in the pharmaceutical industry; laboratory experience at the secondary education level. Aseptic manufacturing experience preferred. PI119423691

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview Entry level position to Compounding Department with emphasis on ensuring that equipment used to process aseptic and non-aseptic products has been cleaned, sanitized or sterilized, as required by specific documentation or procedures. This entails performing automated and manual equipment cleaning prior to sterilization, placing cleaned equipment into autoclaves, starting and monitoring autoclaves, unloading equipment from autoclaves, and delivering equipment to areas of use. This is a 2nd shift position. Responsibilities Follow manufacturing procedures specific to the task being performed. Support to compounding functions as deemed necessary by operations management and functions where qualified to perform. Support may include active batching functions. Operation of processing equipment, and the execution of manual and automated cleaning, sanitizing, and sterilization of tanks and equipment. Perform integrity testing of filters using automated filter integrity test equipment. Able to follow detailed diagrams and written instructions to assemble or disassemble equipment, configure equipment to be washed, configure equipment to be autoclaved. Show progression in competency in all aspects of the position. Demonstrate aptitude and capability to perform multiple tasks at the same time. Able to successfully pass sterile gowning qualification within a 1 month time limit. Perform environmental monitoring at grade level C and D room classifications Utilize knowledge to actively demonstrate process trouble-shooting capabilities whenever possible. Ability to maneuver drums and equipment in excess of 50 lbs and the capability to lift weights up to 50 lbs. Maintain accurate and complete documentation in fulfillment of all duties. Understand and comply with current SOP and GMP requirements relevant to the position. Maintain professional, courteous, and effective communication with all co-workers, customers, and contractors in the execution of all job functions. Perform job responsibilities in a safe and efficient manner, maintaining a clean work environment. Assist supervisors and process manager in all other duties as assigned. Proper use of personal protective equipment at all times is required. Perform routine maintenance on process equipment. Perform area cleaning to maintain compliance using phenolic cleaners and sporicidal agent. A full face respirator or PAPR will be required to be worn for this position. Review MBRs throughout process to assure compliance to good documentation practices. Be available for unscheduled and scheduled overtime throughout the work week and weekend when requested. Qualifications EDUCATION: High school diploma or general education degree (GED) required. EXPERIENCE: A minimum of 1-3 years of relevant experience in the pharmaceutical industry; laboratory experience at the secondary education level. Aseptic manufacturing experience preferred. PI119423687

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Manager, Commercial Services is responsible for providing leadership in the management of the overall business relationship of contract manufacturing customer accounts with the goal of maximizing customer service and customer satisfaction while following internal processes and utilizing internal systems. This role maintains a full understanding of client programs and commercial orders managed throughout the order fulfillment process from receiving forecasts to delivery on purchase orders. The scope of the position covers the following major areas 1) customer relationship management (internal and external), 2) finance and forecast management, 3) Support for Purchasing and Logistics 4) Project Management for post-approval/post-launch product changes and, 5) Support for new Business Development. This role acts as the primary liaison between Renaissance and the external customer, maintaining an understanding of pharmaceutical manufacturing and product development requirements. This role also serves as the internal customer advocate while balancing Renaissance's requirements and priorities. This role leads cross functional teams to ensure there is prompt resolution of issues and challenges related to commercial manufacturing requirements. This role is exempt from overtime. Responsibilities Customer Relationship Management Serves as the primary liaison between the client and the internal departments. Responsible for leading client facing meetings and ensuring meeting documentation is available and complete Develops action plan(s) for a client in order to optimize service levels while still meeting internal company objectives. Conducts regular business review meetings that include a scorecard review of critical metrics. Organizes and manages client site visits. Ensures that required planning and technical information is being exchanged appropriately between organizations. Identifies key client contacts and events and ensures appropriate engagement of internal stakeholders Financial and Contract Acumen Understands and implements the key milestones identified in the client contracts; pricing, payment terms, term of contract, liability and renewal options etc. Assists with the development of the annual commercial forecasts/budgets. Works with Customers and Finance to ensure payment processes are established and meet both companies requirements. Participates in the negotiation of new client contracts and or updates existing contracts as necessary. Commercial Delivery Manages and communicates all logistical issues related to the Client's commercial service, including coordinating client requests to the internal teams and working with site personnel to ensure client delivery requirements and priorities are visible and are being processed appropriately. Understands and monitors forecast and production volumes, capacity issues and cycle time and scheduling parameters Receives Purchase orders, reviews accuracy of pricing and delivery dates based on contractual obligations. Manages customer's on hand inventory including client-supplied materials, obsolete, slow moving and works with customers on disposition decisions. Works with the client and our internal team members to address issues and risks associated with achieving product delivery and develop risk mitigation plans. Manages Bill of Material implementation on behalf of the customer to ensure proper materials are utilized for commercial orders. Coordinates all product changes to the commercial products, including obtaining all client approvals to administer the change Participates in the Annual Pricing review and creates the pricing schedule and letter to review with the client. Product Management Facilitates product related process changes and identifies the resources and actions needed to implement the changes (scope of work definition). Manages and communicates all logistical issues related to the product development services, including coordinating client requests to the internal teams and working with site personnel to ensure client delivery requirements and priorities are visible and are being processed appropriately. Develop creative solutions to technical and organizational problems in order to keep projects on schedule. Collaborates with site management to solve challenges associated with commercial order fulfillment. Oversees and utilizes Account Coordinators as necessary to accomplish job responsibilities Other duties as assigned. Qualifications Bachelor's degree in Science and/or Engineering from a four-year college or University is required. Master's degree is preferred. Minimum 5 years of related experience is required. Combination of project management, pharmaceutical product development, supply chain and management experience is required. Minimum 3 years' experience in a supervisory and management level capacity is required. In addition, must have held a number of positions with increasing levels of responsibility. Excellent communication skills, both written and verbal, with the ability to address issues appropriately with senior management, peers and subordinates in an exceedingly diverse environment. Well defined business development and negotiation skills. Computer literacy, including expertise with Microsoft Word, Excel, PowerPoint and other relevant software. Superior problem-solving abilities, intellectual curiosity and a propensity for dealing with complex issues in a practical, cost-effective manner. Demonstrated leadership skills and interpersonal effectiveness. PI119423683

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The EHS Manager is responsible for planning, organizing and controlling the facilities' environmental programs on a daily basis with responsibility for results in terms of costs, methods, and employees. A key responsibility is compliance with federal, state and local environmental regulations. The incumbent develops and administers programs and systems to achieve an optimal control or reduction of the hazards and exposures in the workplace to ensure operational compliance, reduce waste, promote recycling and prevent pollution. At a minimum, such programs and systems must meet all requirements as set forth by OSHA. Supervises all waste disposal activities and tracks all data including budgetary information and acts as an advisor to subordinates to help them meet schedules and/or resolve technical problems. Frequently interacts with customers and other groups at the Site and coordinates EHS activities accordingly. Serves as an advisor to staff and managers of other areas to help them meet schedules and or resolve technical problems. Insure Standard Operating Procedures and protocols are maintained and applied. This role is exempt from overtime. Responsibilities • Lead EHS improvement projects with a focus on implementing and sustaining an EHS Management System at the site. Holding primary responsibility for the electrical safety, powered industrial truck, LOTO, contractor safety, machine guarding, risk assessment, and job safety analysis programs. • Liaison with Site staff to resolve specific EHS related issues and improve Site performance. Advise on technical procedures, techniques and equipment, and maintain conformance with specific standards. • Develop and implement EHS programs. Develop, implement, monitor, and evaluate EHS programs and systems designed to improve the Site's overall EHS risk profile. • Conduct incident investigations including those resulting in injury, property damage and near miss incidents and equipment and process safety reviews for Qualification, Re-Qualification, and approval to the change control process. Document findings and assist in implementing and tracking corrective and preventative actions. • Administer the air pollution control program, including completion of permits for new sources. Track emissions and fuel usage for the annual emissions inventory. Track VOC emissions and submit all applicable reports and renewal permits. • Accountable for annual reports for the NJRTK chemical inventory and any subsidiary reports such as TCPA, TSCA, etc. • Assist in formulating and implementing the short and long-range goals and KPIs for the EHS Group; set priorities, assign responsibilities, and establish timetables. Project future needs and formulate strategies consistent with projections. • Assist in the determination of fiscal requirements and in the preparation of budgetary recommendations. Recommend purchases of major capital equipment. • Evaluate and recommend new techniques and technologies. Install and maintain EHS systems and programs in compliance with federal regulations. • Represent the department in interactions with other departments and clients. • Coordinate the functions and operations of the EHS Group with other Renaissance departments. • Develop, and foster good working relationships with external customers and support initiatives required to continually enhance Renaissance reputation with customers. • Develops content and delivery of EHS training. Communicates EHS awareness of performance, trends, initiatives, and concepts. • Lead EHS Committee meetings, sets expectations, and drives the performance and feedback of the group. • Accountable for the safety observation and incident reporting program in an effort to foster and cultivate a culture of Incident and Injury Free workplace and hazard identification mitigation. Qualifications Bachelor's degree in Environmental Science, Occupational Safety & Health or a related degree with a minimum of 7 years of relevant experience or equivalent combination of education and experience is required. Three of those years must have been in a supervisory role. Master's degree in an Environmental Science field preferred. Professional Certifications (CSP/REM/CHMM/CIH) are a plus. PI119423685

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview This position is responsible for supporting the Cleaning Validation program requirements (i.e. included but not limited to equipment processes and procedures that support commercial and new R&D drug development activities for Renaissance, for all delivery systems manufactured in the Lakewood, NJ plant). This position is also responsible for generating and executing validation protocols and providing written reports.This is a salaried position and exempt from overtime pay Responsibilities 1. Lead and perform risk assessments for determination of most critical cleaning conditions and acceptance criteria. 2. Review cleaning related method validations including specific and non-specific analytical methods, extraction studies, and recovery studies as applicable. 3. Write, review and execute cleaning development and Validation protocols including lab scale coupon studies, full scale spray coverage testing, and full-scale cleaning recipe and procedure development, as applicable. Perform validation activities within an aseptic and sanitary pharmaceutical environment. 4. Responsible for development final reports summarizing development data and risk assessments for determination of cleaning matrix, family approach, and critical cleaning parameters for validation. 5. Responsible for summarizing results and conclusions when writing final reports. Ensure final reports and study data is reviewed and approved in a timely manner after execution is completed. 6. Perform sampling for cleaning studies including collection of rinse water sampling and surface swab sampling and the submission of samples to QC lab for testing. Perform statistical analysis and evaluation of data to draw technical conclusions and make decisions. 7. Coordinate and schedule cleaning development, validation and, continuous monitoring/verification activities with appropriate departments. 8. Review of Master Batch Records. Ensure the content of the batch records meet the validated state of the process. 9. Lead the investigation of deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation. 10. Write and provide training on SOPs relevant to cleaning validation procedures. Evaluate cleaning procedures and revise with process improvements as necessary. 11. Train other personnel on rinse sampling and surface swab sampling. 12. Review technical and quality system documents such as SOPs, Change Control and Deviation Reports, Batch Production Records, as they relate to validation and regulatory compliance issues. 13. Interfaces with other departments in support of cleaning validation activities. Participate in cross functional activities to support overall Validation department. 14. Additional duties as assigned. Qualifications Bachelor's Degree (BA or BS) in a Science, Engineering or other related field required. Prefer at least 2 - 3 years of relevant experience in the pharmaceutical industry, preferably in a sterile manufacturing environment. Has knowledge and understanding of cGMP, ICH Q7 and FDA guidelines. Must have experience in the principles and approaches of product/equipment cleaning validation PI119423681

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview Perform activities including, but are not limited to mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines while following FDA regulations, cGMPs, OSHA requirements, company practices and company policies. This position may also include light facilities maintenance. This is a 2nd shift position Responsibilities • Perform Line change over, set-up, start-up, including vision system training and data collection • Identify parts needed for repairs using parts manual for specific equipment and will assemble requisition for supervisor to order parts. • Responsible for on-going preventative maintenance of machinery or equipment • Required skills include, but are not limited to, mechanical, electrical, pneumatic, and troubleshooting and repair of packaging and production machines. • Maintain, repair and troubleshoot electronics on all production equipment on the sterile filling and packaging lines to minimize production downtime. • Use computer and logic controllers to perform system analysis of equipment. • Troubleshoot and repairs logic controls/PLC, steam regulators, steam traps, steam strainers, steam valves, temperature control loops associated with autoclaves, tunnels, ovens. • Troubleshoot vision systems and automated weight checkers • Fabricate and install simple control systems to enhance line performance. • Perform changeover of packaging line equipment from one size and product to another accurately documenting the activities in accordance with procedures. • Ability to be a team player; works cooperatively with others to solve problems and proactively helps others when assistance is needed. • Experience in FDA regulated environment • Shift flexibility per business needs, and willingness to work overtime • Demonstrated ability to be flexible and open to change, self-directed, motivated, and task oriented • Make effective decisions and take action based on deductive reasoning and potential product impact. • Identify improvement opportunities in given processes / procedures • Possess strong team skills with the ability to promote clear and thorough communication both written and oral as well as through electronic means. • Must be able to be gowned qualified and maintain gowning status Qualifications High school degree, with a Minimum of 5 years of relevant mechanical experience; or equivalent combination of advanced education and experience. Experience in an aseptic/pharmaceutical packaging environment preferred. PI119441778

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Project Engineer is responsible for managing construction and engineering projects in a cGMP environment through planning, organizing and controlling all elements of the project. Have the ability and competency to oversee all facility and utility upgrade projects. Apply engineering principles to support operational initiatives such as equipment reliability enhancement, environmental sustainability, project execution standardization and continuous improvement. Ability to work in a fast-pace environment and the competence to concurrently handle multiple projects and operational initiatives. Responsibilities • Manage small, medium to large projects from requirement specifications & design to implementation and validation phases • Drive and ensure compliance with all federal and state regulations, including OSHA, DEP, EPA, FDA. • Create detailed project plans and schedules using MS Project to drive successful project outcome, while driving accountability. • Prepare project support documentation, including: project scopes, presentation of conceptual designs, capital requests, purchase orders, project plans and schedules using MS Project to drive successful project outcome, user/functional specifications, design specifications, piping and instrumentation diagrams, process flow diagrams, start-up and equipment operational procedures and commissioning. • Control project cost by ensuring robust contractor agreements are in place, prior to commencing any work, and by closely monitoring and approving capital expenditures. • Prepare and review contractor bids, interviews and vendor selection. • Ensure appropriate communication to all project stakeholders through meetings, project reports, and other forms of communication. • Design and specify HVAC systems and other utility solutions (WFI Water, Compressed Air, Vacuum, Clean Steam, Nitrogen, etc.) in support of manufacturing, packaging and laboratory spaces. • Knowledge of cGMP manufacturing space construction in compliance with ISO 14644 Cleanroom standards. • Knowledge of Building Management Systems and Computerized Maintenance Management Systems. • Perform design review for all construction related designs: mechanical, electrical and plumbing. • Assist in the design review, factory acceptance, site acceptance, installation of equipment, as well as equipment qualification • Evaluate equipment performance and provide improvement recommendation for equipment optimization, while ensure safe operation. • Support compliance activities, such as change control, deviation management and CAPA resolution • Assist in investigations of facility equipment, utility systems, and control anomalies as well as safety incidents. • Write and modify procedures for the proper operation of new and/or existing equipment. • Propose and implement operational efficiency improvements for facility and utility systems. • Assist with training of operations and maintenance personnel, as needed. • Perform other duties and responsibilities as assigned. Qualifications B.S. degree in Mechanical, Electrical Engineering is required. 3 to 7 years of relevant experience in the pharmaceutical industry and PMP certification is a plus. Must possess: • A thorough knowledge of construction in a cGMP environment, HVAC design and controls requirements. • Advanced knowledge of engineering documentation required for cGMP processing and substantial knowledge of cleanroom design and operation. • Extensive knowledge of project management, utilizing PMO standards PI119441800

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview Operate filling equipment in a controlled or non-controlled area to fill and seal product into containers as specified by batch record, and in accordance with all operational SOPs and cGMP requirements. The Gown Qualified Operator is responsible for the full spectrum of duties in assigned filing room. This may include but is not limited to: set-up of room and equipment for production, operate equipment to meet product specifications and batch record requirements, ensures correct components and product according to production schedule and batch record, equipment and room cleaning and sanitization, etc This is a 3rd shift position. Responsibilities Exemplify Renaissance Core Values Performs job functions in conformance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) specifically associated with assigned tasks and generally as a Renaissance employee. Performs in-process sampling such as weight checks, stopper height checks, machine challenges, etc. Regularly work within the controlled areas (classified and non-classified) Maintains control of environmentally controlled areas through cleaning and sanitization of the controlled environments on a regular basis. Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP). Operate equipment within assigned controlled non-classified and controlled classified areas. Monitor process controls regularly and report any abnormalities observed to area and/or quality supervision. Represents Operations as the process owner. o Reports any observation made that can potentially harm the product, process, or business objective. o Provides guidance to those observed not following procedures. o Reports any safety concerns to area supervision and/or EH&S. o Share operational knowledge with peers, new-hires, contingency staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance. o Provides ideas for process improvements. Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business Qualifications One of the following 3 scenarios is required to be considered for the role of a GQO: 3 years of relevant experience + High School Diploma 2 years of relevant experience + Associate's Degree 0 prior relevant experience + Bachelor's Degree Note: Personnel with experience must not have been disqualified from the aseptic areas in the past 12 months. PI119423677

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Director of MS&T is responsible for development, scale up, and transfer of production processes into commercial manufacturing. This is a salaried position and exempt from overtime pay. Responsibilities • Responsible for developing new production processes including the establishment of batch size, equipment selection, determining critical process parameters, and execution of engineering batches. • Responsible for tech transfer of existing processes into Manufacturing. • Responsible for troubleshooting and process improvement for existing commercial products. • Partners with Product Development, Manufacturing and Validation to ensure a robust New Product Development Lifecycle. • Ensures that all safety requirements are understood and followed. • Ensures that all operations are compliant with current Good Manufacturing Practices. • Ensures that all operations are compliant with DEA and other regulatory requirements. • Develops future leaders, Supervisors and Managers with a focus on accountability and servant leadership. • Ensures appropriate training is available to all team members. • Partners with the Director of Operational Excellence to drive a culture of continuous improvement. • Partners with the Director of Engineering to develop or acquire new automation and production technology. • Responsible for ensuring appropriate resources and outstanding execution to achieve business objectives and customer requirements. Qualifications • A minimum of 10 years of leadership in Pharmaceutical Development or Tech Transfer. • Demonstrated expertise in aseptic and injectable manufacturing. • Excellent coaching and mentoring skills. • Excellent tech writing and problem solving skills. • Masters Degree in Engineering, Chemistry, or Pharmaceutical Science; PhD or MBA Preferred. PI119423679

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Gown Qualified Technical Operator will operate equipment to fill and seal product into containers within a controlled environment and maintain areas to a controlled status in accordance with all operational records, SOPs and cGMP requirements. The Gown Qualified Technical Operator (GQTO) is responsible for the full spectrum of job duties currently held by Gown Qualified Operators. In addition, the GQTO will be responsible for environmental monitoring of the controlled areas, coordinating assigned tasks with team members and aseptic setups of rooms, product contact trains and component trains in the filling areas. This is a 1st shift position Responsibilities • Exemplify Renaissance Core Values • Performs job functions in conformance to current Good Manufacturing Practices (cGMP) and Standard Operating Procedures (SOP) specifically associated with assigned tasks and generally as a Renaissance employee. o Maintains qualifications/proficiency through continual training and monitoring. • Performs in-process sampling such as weight checks, stopper height checks, machine challenges, etc. o Following the specifications of the filling record, packaging record, or protocol. • Regularly work within the controlled areas (classified and non-classified) o Properly gown in conformance to the approved gowning procedures associated with the classification being entered. o Exhibit good aseptic technique while working in assigned controlled area. • Maintains control of environmentally controlled areas through cleaning and sanitization of the controlled environments on a regular basis. o This includes sanitizing equipment/machine surfaces, ceiling, walls, floors, etc. o Routine gowning o Component and material transfer. • Maintain complete and accurate documentation of assigned job functions in accordance to Good Documentation Practices (GDP). • Operate equipment within assigned controlled non-classified and controlled classified areas. o Including but limited to automated and manual washers, tunnels, fillers, cartoners (non-controlled) and labelers (non-controlled areas). o Operate equipment in non-controlled areas as needed. o Assist others through training and mentoring. o Make minor adjustments (fill weights, torque, etc.) as needed to maintain process control. • Monitor process controls regularly and report any abnormalities observed to area and/or quality supervision. • Represents Operations as the process owner. o Reports any observation made that can potentially harm the product, process, or business objective. o Provides guidance to those observed not following procedures. o Reports any safety concerns to area supervision and/or EH&S. o Share operational knowledge with peers, new-hires, temporary staff members, and newly-appointed operators, as needed, to maintain efficiencies and cGMP compliance. o Provides ideas for process improvements. • Participate in team efforts to improve our work environment, product quality, efficiencies, and other initiatives identified as being beneficial to our business. • Performs monitoring of processes within controlled areas to ensure control is maintained in these critical areas. o Performs personnel monitoring within the controlled areas. o Performs viable and non-viable monitoring during static and dynamic conditions. o Obtains all supplies required to monitor the controlled areas. o Delivers samples to the Microbiology Lab for further evaluation. • Coordinates assigned tasks with team members as directed by reporting supervisor. o Coordinates cleaning/sanitization activities. o Coordinates job rotation. o Coordinates filling activities. • Performs aseptic setups of product and non-product contact parts. o Filling equipment in sterile and non-sterile processes. Qualifications One of the following 3 scenarios are required to be considered for the role of a GQTO: 3 years of relevant experience + High School Diploma 2 years of relevant experience + Associate's Degree 1 year of relevant experience + Bachelor's Degree Note: Personnel with experience must not have been disqualified from the aseptic areas in the past 12 months. PI119423673

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Scientist II will provide technical support for routine testing activities and conduct physical and chemical analysis of samples, products and materials. Primarily responsible for technical transfer and validation of methods to support quality control testing of products and materials. Identify basic technical problems, atypical test results or methodology malfunctions and assist in the investigation to correct them. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects within time limits and budgetary constraints, performing mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and investigations. Participate in departmental training and provide guidance to junior staff members. This is a 2nd shift position (3:00 pm - 11:30 pm) This is a salaried position and exempt from overtime pay. Responsibilities Accurately generate data using validated test methods and SOPs in a cGMP environment. Demonstrate technical competence in the use of wet chemical techniques and instrumentation pertinent to the job including: IR Infra-Red Spectroscopy UV/Vis Ultra Violet/Visible Spectroscopy GC Gas Chromatography HPLC High Pressure Liquid Chromatography UPLC Ultra High Pressure Liquid Chromatography AA Atomic Absorption Spectroscopy Dissolution apparatus Compendial testing (USP EP, FCC) - ex. Monograph assay, limits tests, chemical and physical tests Responsible for analyzing data, maintaining accurate and detailed written records and notebooks and thoroughly reviewing lab notebooks ensuring compliance to test methods and specifications. Ability to work in a team environment. Train other Scientists and Lab Technicians in various methodologies. Maintain training logs to comply with current SOP requirements. Ensuring safety regulations are adhered to in the laboratory. In the absence of a supervisor or manager oversee the lab schedule and support personnel. . Qualifications Bachelor's Degree (BA or BS) in Chemistry, Biology or related science required. A minimum of 10 years of relevant experience in the pharmaceutical industry; or equivalent combination of education and experience. PI119423675

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview This position is responsible for planning, organizing and controlling Facilities and Critical Utilities Maintenance activities on a daily basis with responsibility for results in terms of costs, methods, and employee management. The incumbent develops and administers schedules and performance requirements for Facilities and Engineering staff to drive continuous improvement and sustainable organizational growth, and acts as an advisor and mentor to direct reports to help meet schedules and/or resolve technical problems. Frequently interacts with suppliers and contractors to improve building, equipment, and processes around the plant. The incumbent interfaces with internal and external stakeholders, Regulatory Compliance, QA, Operations, Planning and Regulatory Agencies (i.e. FDA & EMA). Coordinates and plan maintenance activities accordingly to enhance asset performance. Provide technical support to the entire engineering group and cross-functional teams, as needed. Ensure Standard Operating Procedures and protocols are maintained and adhere to, while ensuring that the group remains in compliance with all regulatory and safety requirements. A brief description of the job's primary purpose or contribution to the department or organization. Assist in the development and implementation of Site's capital plan. Implement and drive a systematic approach for tracking asset reliability and availability in support of production activities, including WFI and USP Water systems, Central Compressed Air System & HVAC. Manage facility related projects, including office space management. Ensure efficient and safe operation of the Lakewood site by providing world class maintenance service in compliance with regulatory requirements. As a member of the Site's Management team, participate in the successful execution of site strategy and policies. This is a salaried position and exempt from overtime pay. Responsibilities Technical • Manage and coordinate facilities related capital projects such as modification of offices and laboratories, as well as construction of new offices and laboratories with responsibility for results in terms of costs, methods, and employees; including the coordination and supervision of outside contractors, vendors and consultants. • Manage the maintenance and sustainability of all critical utilities such as Electrical Systems, WFI and USP Water Systems, Compressed Air System, HVAC Systems, including Boilers and Clean Steam Generators. • Responsible for the maintenance management systems (i.e. BAS and CMMS), including the 24/7 alarm monitoring process. • Responsible for groundskeeping, including landscaping and snow removal. • Manage overall compliance requirement for the group, including change management, deviation management and OSHA regulations. • Coordinate office moves, security system modifications and landscaping activities with responsibility for results in terms of costs, methods, and employees; including the coordination and supervision of outside contractors, vendors and consultants. • Develop, implement and maintain Department policies and procedures. • Lead the expanded use of productivity improvement tools with the group. • Liaison with cross-functional stakeholders to solve specific operating problems and improve Facilities and Critical Utilities maintenance performance. • Provide recommendation and input on technical procedures, techniques and equipment performance. • Responsible for general facility maintenance, Pest Control Management, Janitorial Services, Roof Maintenance and refrigeration systems (i.e. Stability Chambers, Incubators, Refrigerators and Freezers. • Assist in formulating and implementing short and long-range goals for the group; set priorities, assign responsibilities, and drive high performance. • Perform future need forecast through asset life expectancy management and closely monitor building infrastructure to ensure long term sustainability and successful growth of the organization. Communications • Represent the department in interactions with cross-functional stakeholders. • Interface and coordinate with cross-functional team members to successfully achieve the Engineering department's goal and the overall Renaissance organization goals. • Develop, and foster good working relationships with internal and external stakeholders and support initiatives required to continually enhance Renaissance's reputation. • Strengthen inter-departmental relationships at the Manager level. People Management • Primarily responsible for the recruitment, selection and mentoring of employees for the group. • Assure that the Facilities and Engineering staff are properly trained in Standard Operating Procedures (SOPs) and equipment specific requirements. • Plan and schedule work for the group to ensure proper distribution of assignments. • Plan and conduct meetings with direct reports to ensure compliance with established practices, implement new policies and keep employees abreast of current changes and standards. • Monitor employee performance and provide appropriate and timely recognition of their contributions. • Ensure adequate training and development opportunities for Facilities and Engineering employees. • Assist employees in setting career goals and managing career expectations. • Provide guidance as requested regarding hiring, training, promotions, and disciplinary issues for technical personnel. • Understand and comply with all Renaissance safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations including cGMP, ISO, OSHA, GLP and other applicable standards. Qualifications Bachelor's degree in Engineering required along with substantial experience and a proven record of achievement. A minimum of 10 years of relevant experience in the pharmaceutical industry is required, including at least 3 years' experience leading a Facilities or Engineering group. PI119423671

Renaissance LLC All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Overview The Laboratory Information System Administrator (admin) has in depth knowledge of internal business processes and systems. That knowledge is leveraged to improve, assist and direct others with their operational requirements as it relates to all standalone and networked laboratory systems. The admin is also an organized, clear thinking problem solver. Using various available tools to analyze data, resolve issues and offer methods to improve and streamline internal processes. Knowledge of SQL (Structured Query Language) as well as the ability to present and report information obtained from various databases is required. Reviews all lab system designs and integration of systems, i.e. ERP-LN, provides backup recovery and makes recommendations regarding enhancements and/or improvements. Maintains security and integrity controls. Formulates procedures relating to database management. The ability to accomplish multiple tasks in a rapidly changing environment is essential as well as the requirement to manage larger scale projects / upgrades. Corporate wide interaction with all levels of management and departments is crucial. Direct liaison with vendors for ongoing software updates as well as licensing contracts. Responsibilities • Responsible for day to day support of all lab systems for Lakewood site • Provide IT Help Desk solutions where necessary for all lab systems in a timely manner. • Manage all updates to the lab system and write the functional specifications for all future enhancements to the system. • Act as the liaison between Renaissance and vendors when it comes to issue escalation, updates, and upgrades. • Keep detailed track of all code updates and keep the test and production environments in sync. • Preform other IT duties that may be assigned over time, to assist in the possible maintaining of other lab systems. • Manage LIMs environment, LIMs user management, issue resolution, system setup and backup, user training and other related LIMs activities. • Prepare and maintain IT SOPs for LIMs for Lakewood site. • Develop and define technical solutions to business problems along with analyzing and documenting specifics. • The LIMs admin is responsible for creating and reviewing business processes, identifying and addressing operational functionality of the LIMs. Identify opportunities to improve efficiency workflows within the corporate environment. • SSRS (SQL Server Reporting Services) and Crystal Reports coding required for backend data analysis. • Strong knowledge of Microsoft Excel, Word, Visio, PowerPoint and Project. • Strong understanding of Empower5. • Initiate and write Trackwise change controls when applicable for changes to the lab systems. Qualifications Bachelor's degree with a minimum of 5 years of relevant experience in the pharmaceutical industry or equivalent combination of education and experience, strong knowledge of Empower 5 and other lab systems. PI119101605