Engineer II, Process Validation

Overview

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. It is an on‑site role.

• Design, execute, analyze, and summarize deliverables across the three stages of process validation supporting process characterization and qualification for critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and a lifecycle approach.
• Drive risk‑based approaches using tools such as pFMEA, risk ranking, criticality assessments, and apply statistical tools to evaluate process performance, including process capability, trend analysis, 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.
• Provide technical writing support for deviation investigations, root cause analysis, and risk assessments.

• 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 with a thorough understanding of the manufacturing process.
• Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures.
• Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments.

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

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

Aldevron offers a broad array of comprehensive, competitive benefit programs that add value beyond the job, including health care benefits and paid time off. For more information, visit Danaher Benefits Info.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities.