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Process Engineer

  • Location: Warren Township
  • Job Type:Contract

Posted 21 days ago

  • Expiry Date: 29 October 2021

​​Job Description:

Onsite Position with flexibility of working remote. Need local candidates only

  • We are looking for a Process Engineer to join the External team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The position will be responsible for the routine MSAT support to our ex-US CMO partners. This engineer will have responsibilities like an internal MSAT organization for Celgene’s cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement. This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support. The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up workforce training.

Responsibilities:

  • Provide technical process support for routine clinical and/or commercial cell therapy manufacturing at the CMO.

  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements

  • Identify and propose continuous process improvement projects to management.

  • Support process and procedural changes to improve manufacturing performance, robustness, productivity, safety, and efficiency.

  • Perform monitoring of manufacturing processes to understand process capability.

  • Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.

  • Leverage and maintain strong relationships with external partners

  • Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites

  • Maintain permanent inspection readiness and actively support regulatory inspections

  • Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network

  • Share operational and process learning with the rest of the manufacturing network.

Education and Experience:

  • B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline

  • Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)

  • Experience working within Quality Management systems including providing deviation, investigation, and CAPA support

  • Experience with cellular therapies is strongly preferred

  • 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

  • Excellent communication, writing, organizational, teamwork, and presentation skills

  • Strong interpersonal and leadership skills to work with teams in different functions and organizations

 About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.