Aldevron
Life Sciences
Sr.ValidationEngineer,ProcessValidation
Neural analysis suggests this role is
optimal for Senior candidates.
“Sr. Validation Engineer, Process Validation at Aldevron. Skills: Process Validation, Validation, cGMP, Risk assessment. Oversee validation documents. Mentor junior associates”
Industry & Context.
Resolve quality issues; Risk assessments; Root cause analysis
10% travel
What They're Looking For.
Must Have
Bachelor's degree in Engineering or Scientific field, 5+ years of experience, MS degree with 3+ years of experience, PhD in Engineering or Scientific field with 2+ years of experience, Experience in process development, Experience in engineering, Experience in process validation
Nice to Have
Experience working in CDMO environment, Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines
What You'll Do.
Oversee validation documents
Mentor junior associates
Develop validation policies
Implement validation procedures
Provide subject matter expertise
Resolve quality issues
Lead lab investigations
Develop implementation plans
How You'll Work.
Team & Collaboration
Collaborative spirit; Work with product team
Full Job Description
**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](https://danaher.com/our-businesses) 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](https://www.danaher.com/how-we-work/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
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