28 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 incumbent reviews the deviations, change controls and validation documents with minimal supervision. The incumbent is involved in review of deviations for manufacturing process deviations and out-of-specification results through the various phases of the process. The incumbent participates in meetings related to deviations, CAPAs, and change controls. To prepare periodic performance reports. The incumbent will prepare annual product review reports. Responsibilities • Review batch record documentation for accuracy and completeness as per Regulatory guidelines, GMPs and company procedures. • Maintain follow-up with the other internal departments and external clients...

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 incumbent reviews the deviations, change controls and validation documents with minimal supervision. The incumbent is involved in review of deviations for manufacturing process deviations and out-of-specification results through the various phases of the process. The incumbent participates in meetings related to deviations, CAPAs, and change controls. To prepare periodic performance reports. The incumbent will prepare annual product review reports. Responsibilities • Review batch record documentation for accuracy and completeness as per Regulatory guidelines, GMPs and company procedures. • Maintain follow-up with the other internal departments and external clients...

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 Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, physics, and equipment engineering. Responsibilities • Define and specify cGMP process equipment, piping and controls related to the creation of products that improve process capability and production volume while maintaining and improving quality standards. • Manage small-to-mid size projects related to process equipment and manufacturing. • Assist in the design review, site acceptance and installation...

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 Responsible for evaluating existing processes and configuring manufacturing equipment and systems to reduce cost, improve sustainability, and develop best practices within the production process by applying systems engineering principles and technology of chemistry, physics, and equipment engineering. Responsibilities • Define and specify cGMP process equipment, piping and controls related to the creation of products that improve process capability and production volume while maintaining and improving quality standards. • Manage small-to-mid size projects related to process equipment and manufacturing. • Assist in the design review, site acceptance and installation...

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 I, Quality Control Analytical 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...

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 Master Scheduler will be accountable for driving processes for detailed daily planning schedules, capacity planning and workflow balance for all operations in the plant. The Master Scheduler will help establish and improve daily planning capability. In addition, the Master Scheduler will setup and track key performance indicators (KPIs) that measure the effectiveness of the planning functions and adherence to the schedules. Responsibilities Oversee the processes for generating daily manufacturing orders and work schedules for production areas, to achieve high on-time delivery, a balanced product flow, and level loading of available labor. Plan 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 Scientist I, Quality Control Analytical 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...

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 Master Scheduler will be accountable for driving processes for detailed daily planning schedules, capacity planning and workflow balance for all operations in the plant. The Master Scheduler will help establish and improve daily planning capability. In addition, the Master Scheduler will setup and track key performance indicators (KPIs) that measure the effectiveness of the planning functions and adherence to the schedules. Responsibilities Oversee the processes for generating daily manufacturing orders and work schedules for production areas, to achieve high on-time delivery, a balanced product flow, and level loading of available labor. Plan 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 This position supports validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical projects. Applying a working knowledge of Method Validation theories, practices and concepts, the incumbent works under the direct supervision of senior R&D scientists to execute validation activities. Ensure Standard Operating Procedures and protocols are maintained and applied. Responsibilities Technical • Under the supervision of the R&D Manager or a Senior Scientist, support validation activities of analytical methods and method transfer from R&D to QC labs as per the current SOPs, ICH and FDA guidelines. • Conduct...

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...

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 Stability Supervisor, Quality Laboratory Services oversees and coordinates the daily activities of the Quality Laboratory Services Stability Group to ensure that technical data and documentation generated by Stability function is accurate and meets all established protocol and Client timelines. The Stability Supervisor interacts with other functional departments to ensure Stability services are provided timely, efficiently and in compliance with all Renaissance and cGMP standards. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning,...

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 Sr. Process and Automation Manager is responsible for defining, evaluating, and improving equipment processes and systems. The incumbent will introduce technology, and implement equipment reliability best practices by applying engineering and automated systems principles and technology. Responsibilities • Define and develop processes to ensure robust equipment start up for commercialization. • Manage small-to-mid size projects related to process equipment, automation, and manufacturing. • Assist in the design review, site acceptance, and installation of equipment. • Evaluate and improve manufacturing systems in collaboration with operations and engineering...

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 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. 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...

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 Metrology Supervisor is responsible for the preventive maintenance and calibration program for all analytical laboratory instruments and ancillary laboratory equipment as well as production and warehouse instruments. The position requires supervision of direct reports (metrologists and senior metrologists) in the execution of these duties. The Metrology Supervisor provides coordination of activities of calibration in support of production, warehouse, and analytical laboratories to meet established and expected quality, regulatory and customer requirements. Serves as a coach and mentor to their staff to help them meet their schedules and or resolve technical problems....

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 purpose of this position is to plan, manage, and execute engineering and technical projects from initiation to commercialization. The size and scope of the projects assigned are large and complex, and usually consist of high-profile equipment and process implementations that support development and/or launch activities. The Sr. Project Engineer will own and lead the management of engineering capital related activities in a cGMP environment including planning, organizing, and controlling all elements of the project. Projects include but are not limited to cGMP manufacturing suite design and construction, facility utility and support systems, acquisition of filling 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 Critical Utilities Supervisor coordinates and supervises the critical utilities and infrastructure of the campus in a GMP environment by performing the following duties personally or through direct reports. Responsibilities • Inspects plant infrastructure to ensure facility is in operating condition both inside and outside and has any issues repaired. • Analyzes HVAC systems, lighting, and other facility systems, including fire protection. • Utilizes the computer building management system to troubleshoot/identify HVAC issues • Plans, budgets, and schedules facilities, buildings, and grounds modifications including cost estimates, bid sheets, layouts, 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 This position supervises the daily activities of union and non-union personnel in the compounding, filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines. Responsible for the proper operation of all production activities assigned, such as, scheduling, training, coaching and counseling. This includes but is not limited to: preparing, staffing and operating production lines, interaction with customers, data collection and interpretation, investigation writing, technical report writing, change control, cleaning and environmental monitoring, and safety. Responsibilities • Complete production plan by...

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 supervises the daily activities of union and non-union personnel in the compounding, filling and packaging of sterile and specialty pharmaceutical products in compliance with FDA regulations and cGMP guidelines. Responsible for the proper operation of all production activities assigned, such as, scheduling, training, coaching and counseling. This includes but is not limited to: preparing, staffing and operating production lines, interaction with customers, data collection and interpretation, investigation writing, technical report writing, change control, cleaning and environmental monitoring, and safety. This position is a 2nd shift position and exempt from...

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 Operational Excellence Quality Engineer II will be responsible for driving business transformation in the laboratory areas through the implementation of Operational Excellence tools and culture. Responsibilities • Define, implement, and refine continuous improvement initiatives as an internal coach and change agent with specific focus on our laboratories (analytical, microbiology, spray) • Operate with a sense of urgency to provide tangible improvements in needed areas through lean laboratories and six sigma best practices • Communicate effectively with numerous stakeholders to foster a sense of collaborative improvement • Educate stakeholders at front line and...