Engineer II, Process Validation
Core
Lead and support internal and external validation projects to enable the commercialization of new life-saving medicines in biologics and small/large molecule manufacturing.
Role type
Process Validation Engineer
Builds
Validated manufacturing processes for drug substance and drug product
Domain
Life sciences / Biotechnology / Pharmaceutical manufacturing
Required skills
Process validation (3 stages), Risk-based approaches (pFMEA, risk ranking), Statistical tools (DOE, control charts), Technical writing, cGMP regulations, FDA/EU GMP knowledge
Preferred skills
CDMO environment experience, Sterile fill-finish process, Equipment qualifications
Responsibilities
Design, execute, and analyze deliverables across process characterization and qualification; Drive risk-based approaches and statistical evaluations; Serve as technical SME for clients and during regulatory inspections
Seniority
Mid-level IC