13 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 Process Equipment Manager II is 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. This position is exempt from overtime. 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...

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 performs 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. The Process Mechanic will assess and consider on a daily basis the safety of our employees, the security of our assets and the quality of the services they deliver. This position will also coordinate outside contractors and vendors for various services. The Process Mechanic may also be required to perform facilities maintenance. This is a third shift position and hours are 11:00 pm until 7:30 am....

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 Equipment Manager II is 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. This position is exempt from overtime. 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...

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 an exempt from overtime...

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 is a 2nd shift position Responsibilities •...

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 This position is responsible for duties associated with qualifying manufacturing and packaging equipment and Pharmaceutical utilities, including: HVAC Systems for Clean Classified Areas, USP Purified Water, USP Water-for-Injection, Clean Compressed Air, and nitrogen consistent with cGMP requirements for clinical manufacturing, scale-up and commercial manufacture of sterile and specialty pharmaceutical products. Major job functions include: generation of qualification / validation documents, execution of qualification / validation documents, generation of reports, managing project timelines, and participating in cross functional teams. Responsibilities Responsible...

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. Manager, Sterility Assurance is responsible for the overall performance of the sterility assurance group and its functions. The purpose of this position is to lead a group of scientific personnel in the execution and timely completion of projects. The position is expected to use their knowledge and skills to mentor/advise less experienced members within the group. The individual will manage the sterility assurance group and ensure compliance with all regulatory guidance, Renaissance procedures and good documentation practices. The individual is responsible for being the SME for all related procedures pertaining to sterility assurance and aseptic manufacturing. This...

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 Apply basic knowledge of principles/ theories and concepts to develop solutions to technical problems of limited scope. Perform basic tests and analysis; conduct laboratory procedures in compliance with established protocols. Keep appropriate records, write reports, and provide information to others. Maintain a level of scientific knowledge in assigned area; perform scientific literature searches and evaluations as required and understand/comply with accepted laboratory and safety procedures. This is a 2nd shift position and exempt from overtime Responsibilities Work with vendors. For example: to obtain documents for instrument maintenance or upkeep. May assist...

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 Release Coordinator will coordinate Quality Inspector activities. Support manufacturing services through the review and release of Raw Materials and Components per cGMP and company standards. Ensure Quality Assurance Standards and procedures are met as well as promote continuous improvements. Review and approve conditional release and final release of ASCNs. Provide support documentation during GMP audits. Interact with internal and external clients in preparation for new products (development, clinical and commercial) manufactured at Renaissance. This is a 2nd shift position (3:00 pm to 11:30 pm) Responsibilities Responsible for supporting manufacturing...

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 Scientist II, Development will apply basic knowledge of principles/ theories and concepts to develop solutions to technical problems of limited scope. Perform basic tests and analysis; conduct laboratory procedures in compliance with established protocols. Keep appropriate records, write reports, and provide information to others. Maintain a level of scientific knowledge in assigned area; perform scientific literature searches and evaluations as required and understand/comply with accepted laboratory and safety procedures. This position is a 2nd shift position and is exempt from overtime. Responsibilities Work with vendors. For example: to obtain...

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 Deviation Investigator, Manufacturing will serve as a primary investigator for the Operations Group to ensure timely and accurate completion of high-quality manufacturing investigations and implementation of subsequent corrective actions This will be accomplished largely through leading and conducting appropriate root-cause analyses for events and authoring investigation reports related to compounding, filling, inspection, and packaging of sterile and non-sterile pharmaceutical products. This position is exempt from overtime Responsibilities • Own, lead, and support prompt, thorough, and well-written investigations assuring that root cause evaluations are...

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 Sr. Manager of Compliance 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...