Process Validation Engineer II — Life Sciences

Radiometer; Fargo (ND); On-site; USD 90,000 - 120,000; Full time

Job summary

Aldevron, a Danaher operating company, is hiring an Engineer II, Process Validation in Fargo, ND. This on-site role reports to the Process Validation Manager in Technical Operations and leads critical validation projects for bringing life-saving medicines to market.

You will design, execute, analyze, and summarize validation deliverables across starting materials, drug substance, and drug product, applying risk-based approaches and statistical tools. Travel up to 5% for audits and client visits.

Qualifications

• Bachelor's or master's degree in engineering with 2+ years of experience.
• Experience leading deliverables across process validation in biologics/small and large molecules manufacturing.
• Knowledge of regulatory requirements and cGMP for pharmaceutical manufacturing operations and validation.

Responsibilities

• Design, execute, analyze, and summarize process validation deliverables.
• Support process characterization and qualification across starting materials, drug substance, and drug product.
• Serve as technical SME for process validation with clients and internal teams during audits and inspections.

Skills

Process validation

Statistical analysis

Technical writing

Regulatory knowledge

Travel willingness

Education

Bachelor's or Master's in Engineering

Tools

pFMEA

Control charts

DOE

Job description

Aldevron, a Danaher operating company, is hiring an Engineer II, Process Validation in Fargo, ND. This on-site role reports to the Process Validation Manager in Technical Operations and leads critical validation projects for bringing life-saving medicines to market.

You will design, execute, analyze, and summarize validation deliverables across starting materials, drug substance, and drug product, applying risk-based approaches and statistical tools. Travel up to 5% for audits and client visits.