Engineer II, Process Validation
On-siteFargo, North Dakota, United States
Job Summary
Design, execute, and summarize deliverables across the three stages of process validation for biologics and small/large molecules, covering characterization, qualification, and lifecycle approaches aligned with FDA and EU GMP Annex 15 guidance. Drive risk-based approaches using pFMEA, criticality assessments, and statistical tools for process capability and trend analysis. Serve as a technical SME for external clients and internal teams including MSAT, manufacturing, QC, QA, and RA during audits, inspections, and kaizens. This on-site role in Fargo, ND reports to the Process Validation Manager and requires 5% travel for client support. Bachelor's or master's in engineering with 2+ years in process validation is required.
Required Qualifications
- Bachelor's or master's degree in engineering
- 2+ years of experience
- Prior experience in leading deliverables across all three stages of process validation in biologics/small and large molecules manufacturing
- Thorough understanding of the manufacturing process
- Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices
- Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments
- Ability to travel 5% of the time to support audits and client visits
- Ability to lift, move or carry equipment up to 10 lbs
Desired Qualifications
- Previous experience in a CDMO environment
- Sterile fill-finish process and equipment qualifications
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