Engineer II, Process Validation

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

Engineer II, Process Validation is responsible for leading and supporting internal and external validation projects that enable commercialization of vital new life‑saving medicines.

Responsibilities

• Design, execute, analyze, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
• Drive risk‑based approaches using tools such as pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including process capability, trend analysis and control charts, and DOE interpretation.
• Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events.

Requirements

• Bachelor’s or master’s degree in engineering with 2+ years of experience.
• Prior experience in leading deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train with a thorough understanding of the manufacturing process.
• 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.

Travel & Physical Requirements

• Ability to travel 5% of the time to support audits and client visits.
• Ability to lift, move or carry equipment up to 10 lbs.

Preferred Experience

• Client facing roles such as prior experience in a CDMO environment.
• Sterile fill‑finish process and equipment qualifications.

Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

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