Process Engineer

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.