Engineer I, MSAT

Role: Process Engineer in Manufacturing Science and Technology (MSAT) supporting GMP drug product manufacturing, tech transfers, process development, validation, and continuous improvement. Responsibilities: serve as SME for manufacturing processes, authoring and reviewing technical documents, providing troubleshooting support during cGMP production, leading deviation investigations, supporting validation activities, and identifying process improvements. Collaborate cross-functionally with Process Development, Manufacturing, Supply Chain, Regulatory, and Quality teams, and engage with external clients for tech transfers. Qualifications: BS/MS in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, or Biology with 3+ to 5+ years’ relevant industry experience; strong knowledge of biotech manufacturing, aseptic processing, and regulatory standards; hands-on experience with process validation, investigations, and documentation; familiarity with biotech equipment (e.g., LOVO, Sepax, Rotea). Preferred: certifications like Six Sigma Green/Black Belt. HighValue: biotech or cell therapy manufacturing, cGMP compliance, process validation, tech transfers, deviation investigations, supporting new technology evaluation. Work setup: on-site with routine physical requirements; no specific travel noted.