Engineer II, Process Validation
About The Position
The Engineer II, 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 in Fargo, North Dakota, and is performed on-site. It reports to the Process Validation Manager. The engineer designs, executes, analyzes, and summarizes deliverables across all three stages of process validation, supporting process characterization and qualification for critical starting materials, drug substance, and drug product. The work follows product classifications aligned with FDA guidance, EU GMP Annex 15, and a lifecycle approach. The position also applies risk-based methods and statistical tools to evaluate process performance and serves as a process-validation subject matter expert for clients, internal teams, audits, inspections, and improvement events.
Requirements
- Bachelor’s or master’s degree in engineering.
- At least 2 years of experience.
- Prior experience leading deliverables across all three stages of process validation in biologics or small- and large-molecule manufacturing, with a thorough understanding of the manufacturing process.
- Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations, validation procedures, and practices.
- Proficiency in technical writing, 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.
Nice To Haves
- Experience in client-facing roles, such as prior experience in a CDMO environment.
- Experience with sterile fill-finish processes and equipment qualifications.
Responsibilities
- Design, execute, analyze, and summarize deliverables across the three stages of process validation.
- Support process characterization and qualification for critical starting materials, drug substance, and drug product, using product classifications aligned with FDA guidance, EU GMP Annex 15, and a lifecycle approach.
- 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 interpretation of design of experiments (DOE).
- Serve as a technical subject matter expert for process validation with external clients and internal teams, including MSAT, manufacturing, QC, QA, and RA.
- Support client audits, regulatory inspections, kaizens, and workshop events.
Benefits
- Comprehensive, competitive benefit programs, including health care programs and paid time off.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
