Process Validation Engineer II

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