Engineer II, Process Validation
Core
Leading and supporting 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 II
Builds
Validated manufacturing processes for drug substance and drug product aligned with FDA and EU GMP guidelines.
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 lifecycle management, risk-based approaches (pFMEA, risk ranking), statistical process control (capability, trend analysis, control charts, DOE), technical writing (deviation investigations, root cause analysis), cGMP regulatory knowledge
Preferred skills
CDMO environment experience, sterile fill-finish process qualification
Technologies
pFMEA, DOE, control charts
Responsibilities
Design, execute, analyze, and summarize deliverables across process characterization, qualification, and validation stages; Drive risk-based assessments and statistical evaluations of process performance; Serve as a technical SME for external clients, internal teams, and during regulatory inspections and audits
Seniority
Mid-level IC (2+ years experience)
