Sr. Validation Engineer, Process Validation
About The Position
Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Aldevron, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers . As a member of our team, you’ll help bring life-changing innovations to life—impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you're launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential—one discovery at a time. Learn about the Danaher Business System which makes everything possible. The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron’s Fargo, ND site. As the subject matter expert in validation, this position leads the development, execution, and implementation of validation, practices, policy, and procedures. This position reports to the VP, Global Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role. In this role, you will have the opportunity to: Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design Develop and implement validation policies and procedures based on current regulations and industry standards Provide subject matter expertise during client and regulatory audits, kaizen and workshop events, and manufacturing support Help resolve quality issues and CAPA’s leading lab investigations, risk assessments, root cause analysis, and developing implementation plans
Requirements
- Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) with 5+ years of experience or MS degree with 3+ years of experience. PhD in Engineering or Scientific field with 2+ years of experience.
- Experience in process development, engineering, and process validation required.
- Experience working in CDMO environment is a plus
- Experience using statistical, risk assessment, and process improvement tools
- 10% travel to support routine inspections, audits, and customer projects
Nice To Haves
- Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines
Responsibilities
- Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product
- Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design
- Develop and implement validation policies and procedures based on current regulations and industry standards
- Provide subject matter expertise during client and regulatory audits, kaizen and workshop events, and manufacturing support
- Help resolve quality issues and CAPA’s leading lab investigations, risk assessments, root cause analysis, and developing implementation plans
Benefits
- 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. Check out our benefits at Danaher Benefits Info .
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
