Principal Manufacturing Compliance Engineer
Core
Lead complex technical, regulatory, and compliance issues in biomanufacturing operations, ensuring cGMP adherence and production integrity.
Role type
Principal Manufacturing Compliance Engineer (Biopharma)
Builds
Biopharmaceutical products via mammalian cell culture and purification
Domain
Biopharmaceuticals / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Mammalian cell culture, biopharmaceutical purification, cGMP compliance, FDA/ICH/European regulatory guidelines, Deviation Management Systems (DMS), Root Cause Analysis (RCA), CAPA execution, Change Control, technical writing, cross-functional leadership
Preferred skills
None stated
Technologies
None stated
Responsibilities
Manage and resolve complex technical, quality, and compliance issues; lead Root Cause Analysis (RCA) sessions and coordinate CAPA implementations; perform critical reviews and approvals for process validation protocols and engineering changes; serve as SME to regulatory agencies during site inspections; identify and mitigate technical and microbial contamination risks; drive operational excellence and mentor manufacturing personnel; track and analyze environmental monitoring data and performance metrics
Seniority
Principal, hands-on IC with strategic oversight
