Senior Engineer, Process Validation
About The Position
The Senior Engineer, Process Validation leads and supports internal and external validation projects that enable commercialization of new medicines. The role is part of Aldevron’s Technical Operations Department, is based in Fargo, North Dakota, and is eligible for fully remote work. It reports to the Process Validation Manager. The position develops and executes process validation deliverables across all three stages of process validation, supporting process characterization and qualification for critical starting materials, drug substance, and drug product. It also leads lifecycle management of sterile fill-finish validation strategies and qualification programs for aseptic manufacturing processes. The role applies risk-based and statistical approaches, serves as a technical subject matter expert for clients and internal teams, participates in audits and regulatory inspections, and mentors junior validation associates.
Requirements
- Bachelor’s or master’s degree in engineering.
- At least 5 years of experience.
- Experience leading process development, engineering, and deliverables across all three stages of process validation in biologics or small- and large-molecule manufacturing trains.
- Experience using statistical analysis, risk assessment, and process improvement tools.
- Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations, validation procedures, and practices.
- Proficiency in technical writing, including deviation investigations, root cause analysis, and risk assessments.
- Ability to travel 15% to sites.
Nice To Haves
- Experience with packaging and shipping validation of final product container closure configurations.
- Client-facing experience, such as prior experience in a CDMO environment.
Responsibilities
- Design, execute, and summarize deliverables across the three stages of process validation, supporting process characterization and qualification for critical starting materials, drug substance, and drug product.
- Apply product classifications aligned with FDA guidance, EU GMP Annex 15, and a lifecycle approach.
- Lead the planning, execution, and lifecycle management of sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes.
- Support validation activities for sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging, and shipping.
- Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments.
- Apply statistical tools to evaluate process performance, including process capability, trend analysis, control charts, and design of experiments interpretation.
- Serve as a process validation technical subject matter expert for external clients and internal MSAT, manufacturing, QC, QA, and RA teams.
- Support client audits, regulatory inspections, kaizens, and workshop events.
- Mentor junior validation associates in process validation, cGMP regulations, and Quality by Design principles.
- Travel to sites to support validation project execution, routine inspections, audits, and client visits.
Benefits
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- Bonus/incentive pay
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What This Job Offers
Job Type
Full-time
Career Level
Senior
