Process Validation Engineer II
I'm partnering with a rapidly growing biotech/CDMO organization supporting the development and commercialization of cutting-edge therapies and currently seeking a Process Validation Engineer II to join their Technical Operations team.
This individual will play a key role in process characterization, qualification, and validation activities supporting GMP manufacturing operations across drug substance and drug product processes.
Key Responsibilities:
- Lead and support process validation activities across the validation lifecycle (Process Design, Process Qualification, and Continued Process Verification)
- Design and execute process characterization studies and validation protocols
- Analyze process performance using statistical tools including DOE, control charts, process capability analysis, and trend analysis
- Conduct risk assessments utilizing pFMEA, criticality assessments, and risk-ranking methodologies
- Partner cross-functionally with Manufacturing, MSAT, QA, QC, Regulatory Affairs, and Engineering
- Author technical documentation including protocols, reports, investigations, and risk assessments
- Support client audits, regulatory inspections, and continuous improvement initiatives
What We're Looking For:
- BS or MS in Engineering or related technical discipline
- Experience supporting process validation within GMP pharmaceutical, biologics, biotechnology, or advanced therapy manufacturing environments
- Understanding of FDA process validation guidance, cGMP requirements, and lifecycle validation principles
- Experience with deviation investigations, root cause analysis, CAPAs, and technical writing
- Strong statistical and data analysis skills
Preferred Experience:
- CDMO environment
- Sterile manufacturing or fill-finish operations
- Equipment qualification (IQ/OQ/PQ)
- Client-facing validation support
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