26 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 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...

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...

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...

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...

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...

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...

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 Manufacturing Process Operator reports to the Production Supervisor through the line leader. This person is responsible for safely operating all equipment on any packaging line in controlled and non-controlled areas outside the sterile cores. This person will also be responsible for the inspection of filled product under controlled conditions. Responsibilities Exemplify Renaissance Core Values Run equipment as per the validated machine settings. Gown and work within controlled non-sterile areas. (i.e. Scrubs, Head Cover, Facial Hair Cover (if applicable), shoe covers, gloves, Tyvek hood, coveralls, boots and safety goggles) Inspect micro-suppository for the...

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 Manufacturing Process Operator reports to the Production Supervisor through the line leader. This person is responsible for safely operating all equipment on any packaging line in controlled and non-controlled areas outside the sterile cores. This person will also be responsible for the inspection of filled product under controlled conditions. Responsibilities Exemplify Renaissance Core Values Run equipment as per the validated machine settings. Gown and work within controlled non-sterile areas. (i.e. Scrubs, Head Cover, Facial Hair Cover (if applicable), shoe covers, gloves, Tyvek hood, coveralls, boots and safety goggles) Inspect micro-suppository for the...

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 Microbiology Project Coordinator directly supports in the daily management of multiple projects for our healthcare partners. Specific responsibilities include the creation and maintenance of laboratory timelines and documentation review such as protocols and applicable change controls for the projects. As the laboratory point of contact with the Project Managers and Project Coordinators the individual needs to maintain strong professional relationships with them through setting realistic expectations and timely communications. Responsibilities • Participate in internal, cross-functional teams to ensure project milestones are met as contracted with our healthcare...

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 QC Auditor will provide technical support for routine data integration & reviewing activities of raw materials, finished product, bulk in-process and component documentation. Identify basic technical problems, atypical test results or methodology data integration and assist in the investigation to correct them. Remediate complicated technical issues related complexity of data. Other important duties include ensuring notebooks and reports are in compliance with regulatory guidelines, completing projects data review within time limits and, verifying mathematical calculations, interpreting results, recording observations and responding to and assisting in audits and...

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 Vault Administrator will provide support in day-to-day manufacturing operations to meet the regulatory requirements established by the Drug Enforcement Administration (DEA) and related activities at Renaissance. This is a 2nd shift position. Responsibilities • Primary responsibility for all "Code" entry on their shift of all controlled substance storage locations and acts as the "Verifier" for transactions at each location. • Will serve as primary for all controlled substance sample transfers between buildings • Will investigate program deviations or discrepancies that directly result from transactions acted as the count "verifier" • Will lead inventory cycle...

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...

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...

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...

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 R&D Formulation Scientist II is a position that will support formulation development of new pharmaceutical products through pre-formulation, formulation development/formulation optimization, product development and scale up activities. The candidate will apply a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise and concepts. The incumbent will work under the direct supervision of more senior R&D scientists to plan, execute, and manage product formulations projects. The candidate will provide assistance and interpretation of project results to team members and other business unit personnel....

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 Associate Microbiologist performs various types of microbiological testing under supervision. Evaluates, and records data. Assists lab management and microbiologists as directed. Schedule flexibility is required. This is a 2nd shift position. Responsibilities • Follows current GMP requirements and complies with company safety and controlled substance handling policies. • Participates in repair and maintenance of lab equipment and laboratory housekeeping (disinfection and cleaning). • Initiates, documents, and performs microbiological analysis on received test samples (including raw materials, bulk, final product, stability, water) as per USP, in-house, or...

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 Achieve safe operations of the facility while maintaining continuous (24/7) operations of the gas High pressure steam boilers, water systems and clean steam generators. This is a 3rd shift position. Responsibilities Perform monthly boiler room facility inspections and make sure the boiler feed water chemistry is correct. Read meters and gauges or automatic recording devices at specified intervals to verify operating conditions. Record data such as temperature of equipment, hours of operation, fuel consumed, temperature or pressure, water levels, analysis of flue gases, voltage load and generator balance. Adjust manual controls or overrides automatic controls...

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 QA Specialist will review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures with minimal supervision. To release products, drug product components and container-closures. To review and write cGMP procedures under supervision. To report periodic quality metrics. This position is exempt from overtime. Responsibilities • Review manufacturing batch records, testing results and deviation reports • Interact with other departments to address review observations • Release drug product, drug product components and container-closures • Interact with customers on batch record reviews and batch releases •...

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 QA Specialist will review manufacturing batch records, testing results and deviation reports for compliance with cGMP and company procedures with minimal supervision. To release products, drug product components and container-closures. To review and write cGMP procedures under supervision. To report periodic quality metrics. This position is exempt from overtime. Responsibilities • Review manufacturing batch records, testing results and deviation reports • Interact with other departments to address review observations • Release drug product, drug product components and container-closures • Interact with customers on batch record reviews and batch releases •...

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 R&D Formulation Scientist II is a position that will support formulation development of new pharmaceutical products through pre-formulation, formulation development/formulation optimization, product development and scale up activities. The candidate will apply a solid understanding of theories/practices including those from other disciplines outside the primary area of expertise and concepts. The incumbent will work under the direct supervision of more senior R&D scientists to plan, execute, and manage product formulations projects. The candidate will provide assistance and interpretation of project results to team members and other business unit personnel....