What are the responsibilities and job description for the Process Engineer position at Talent Groups?
We are seeking a motivated professional to support the Gene Therapy External Manufacturing – Starting Materials team. This role focuses on managing and overseeing the production of critical starting materials (plasmids, cell banks).
Key Responsibilities :
- Support GMP production of plasmids and cell banks with internal teams and CMOs.
- Review and author technical documents (batch records, deviations, change controls, qualification reports).
- Analyze process performance using statistical methods and drive continuous improvement.
- Provide technical support for process changes, tech transfers, and troubleshooting at CMOs.
- B.S. / M.S. in Engineering, Life Sciences, or Pharmaceutical Sciences and 1-5 years of relevant industry experience (MSAT experience preferred).
- Knowledge of biologics, cell banking, plasmid production, gene therapy BDS .
- Understanding of cGMP, regulatory requirements, and quality systems .
