Process Validation Engineer II | Biopharma Client-Facing

Aldevron; Fargo (ND); On-site; USD 85,000 - 110,000; Full time

Job summary

Aldevron in Fargo, ND is seeking an Engineer II, Process Validation to lead and support validation projects enabling commercialization of life-saving medicines. You will design, execute, and summarize validation deliverables across materials, drug substance, and drug product, aligning with FDA, EU GMP Annex 15, and lifecycle approach.

You will drive risk-based methods (pFMEA, risk ranking, DOE interpretation) and apply statistical tools to assess process performance, capability, trends, and

Qualifications

• Bachelors or Masters in engineering with 2+ years of experience.
• Experience leading 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 deviation investigations, root cause analysis, and risk assessments.

Responsibilities

• Design, execute, analyze, and summarize validation deliverables across stages supporting process characterization and qualification.
• Drive risk-based approaches using pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including control charts and DOE interpretation.
• Serve as a technical SME for process validation with external clients and internal teams, including audits and regulatory inspections.

Skills

Technical writing

Risk assessment

Process validation

Education

Bachelor's or Master’s in engineering

Job description

Aldevron in Fargo, ND is seeking an Engineer II, Process Validation to lead and support validation projects enabling commercialization of life-saving medicines. You will design, execute, and summarize validation deliverables across materials, drug substance, and drug product, aligning with FDA, EU GMP Annex 15, and lifecycle approach.

You will drive risk-based methods (pFMEA, risk ranking, DOE interpretation) and apply statistical tools to assess process performance, capability, trends, and