Senior Engineer, Process Validation
Core
Leading and supporting internal and external validation projects to enable the commercialization of vital new life-saving medicines in biologics and small/large molecule manufacturing.
Role type
Senior Process Validation Engineer
Builds
Sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes.
Domain
Life sciences / Biotechnology / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process validation (all three stages), risk-based approaches (pFMEA, risk ranking), statistical analysis (process capability, trend analysis, control charts, DOE), cGMP regulations, technical writing (deviation investigations, root cause analysis), mentoring
Preferred skills
Packaging and shipping validation, CDMO environment experience
Technologies
pFMEA, DOE, control charts
Responsibilities
Design, execute, and summarize deliverables across process characterization and qualification; Lead planning and lifecycle management of sterile fill-finish validation; Drive risk-based approaches and statistical tool application; Serve as technical SME for clients and internal teams; Mentor junior validation associates
Seniority
Senior, hands-on IC
