Engineer II, Process Validation (Biopharmaceutical Manufacturing)

Location: On-site in Fargo, North Dakota, United States; approximately 5% travel required for audits and client visits.

Company

Aldevron is a hirify.global operating company providing CDMO services that support the development of genomic medicines and life-changing therapies.

What you will do

• Lead and support internal and external process validation projects for critical starting materials, drug substances, and drug products.
• Design, execute, analyze, and summarize deliverables across all three stages of process validation.
• Apply risk-based tools including pFMEA, risk ranking, and criticality assessments.
• Use statistical methods such as process capability analysis, trend analysis, control charts, and DOE interpretation.
• Serve as a technical subject-matter expert for clients and internal MSAT, manufacturing, QC, QA, and RA teams.
• Support client audits, regulatory inspections, kaizens, and workshop events.

Requirements

• Bachelor’s or master’s degree in engineering and at least 2 years of experience.
• Experience leading deliverables across all three stages of process validation in biologics or small- and large-molecule manufacturing.
• Thorough understanding of relevant manufacturing processes.
• Knowledge of global regulatory requirements, cGMP regulations, pharmaceutical manufacturing operations, and validation practices.
• Technical writing experience in deviation investigations, root cause analysis, and risk assessments.
• Ability to lift, move, or carry equipment weighing up to 10 lbs.

Nice to have

• Client-facing experience, particularly in a CDMO environment.
• Experience with sterile fill-finish processes and equipment qualifications.

Culture & Benefits

• Mission-driven work supporting life sciences, diagnostics, biotechnology, and genomic medicine.
• Collaborative culture focused on belonging, scientific expertise, quality, and continuous improvement.
• Healthcare programs and paid time off.
• Opportunities to work with internal teams and global clients on complex validation challenges.