Process Engineer

Summit, NJ

Posted: 07/19/2022 Job Number: 21162613

Job Description

**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.

Project Description:
  • 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.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Margo: margo@alphaconsulting.Com


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Margo Emling

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