Senior Engineer, Process Validation
$100,000–$130,000 year
RemoteUnited 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 management. Lead planning and execution of sterile fill-finish strategies including aseptic manufacturing, filtration, filling, and container closure integrity testing. Apply risk-based approaches using pFMEA, statistical tools, and DOE to evaluate process performance. Serve as technical SME for external clients and internal teams during audits, regulatory inspections, and workshops. Mentor junior associates on cGMP regulations and Quality by Design principles. Requires 5+ years of experience, a degree in engineering, and 15% travel. Fully remote position in Fargo, ND.
Required Qualifications
- Bachelor or master degree in engineering
- 5+ years of experience
- Prior experience in leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing
- 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 15% to site to support validation project executions, routine inspections, audits, and client visits
Desired Qualifications
- Previous experience in Packaging and shipping validation of final product container closure configurations
- Client facing roles such as prior experience in a CDMO environment
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