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PROCESS ENGINEER SUMMIT, NJ Onsite position with some flexibility to work remotely Required Skills:
- B.S. with 12+ years, M.S. with 10+ years in industry with relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline.
- Experience in leading Technical Transfers is required.
- Experience with cellular therapies is strongly preferred.
- Experience in a regulated manufacturing environment.
- Experience working in a self-driven, performance/results oriented, fast paced matrix environment.
- Strong experience with SOPs, change controls, cGMPs and how to work within a regulatory environment.
- Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting.
- Familiarity with literature on process development and cell therapy.
- Ability to assess risk and develop contingency plans for process risks.
- Excellent problem-solving skills, including issue resolution.
- Detail oriented with excellent verbal and written communication skills.
- Strong interpersonal and leadership skills to work with teams in different functions and organizations.
- We are looking for an Engineer, to join our Tech Transfer team in GMS&T.
- The successful candidate will work under the tech transfer lead, to support process and analytical clinical and/or commercial transfers, support and implement lifecycle changes, and support the training and start-up of new facilities.
- He/she will collaborate with SMEs, user groups, quality groups, and other stakeholders to support the lead to accomplish transfer and start-up goals including: support facility design, provide user specification, process simulations, transfer lot generation, comparability studies, test plan generation, operator training, and troubleshooting.
- He/she will also participate in strategic discussions, anticipate bottlenecks and transfer risks, and address risks/issues proactively, while fostering an environment of teamwork.
- Support the Tech Transfer Lead and interface with process SMEs to develop transfer strategies.
- With direction of the Tech transfer Lead, support the following activities:
- Interface with manufacturing site operations teams and process/analytical SMEs to learn and implement processes, procedures, and analytics.
- Support facility start-up efforts through specification, review, and testing of equipment and electronic systems.
- Coordinate project planning, timeline, communications, and risk management activities.
- Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies.
- Provide technical input and investigation support for deviations/OOS.
- Assist in the management of changes, and in the implementation of process improvements.
- Provide technical input in support of regulatory submissions.
- Interact with other CMC teams including Operations, QA, Development, and Regulatory.
- Foster strong inter-team relationships to achieve common project goals.
- ID: #44466852
- State: New Jersey Summit 07901 Summit USA
- City: Summit
- Salary: $72.85 hr
- Job type: Contract
- Showed: 2022-07-29
- Deadline: 2022-09-26
- Category: Science/biotech