Engineer II, Process Validation

About the role

The Engineer II, Process Validation is responsible for leading and supporting internal and external validation projects that enable the commercialization of vital new life-saving medicines. This position reports to the Process Validation Manager and is part of the Technical Operations Department located in Fargo, ND. The role is on-site.

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 but not limited to 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 training.
• 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.

Qualifications

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

Skills

• Client facing roles, especially in a CDMO environment.
• Experience in sterile fill-finish process and equipment qualifications.

Benefits

Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. These programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.