Process Validation Engineer II

Fargo, ND (Relocation Available) | Onsite

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

Quality Engineer Jobs in North Carolina

Process Validation Engineer II

Quality Engineer Jobs in North Carolina

Process Validation Engineer II