Job Details

Sr. Validation Engineer, Process Validation

Role overview

The Senior Validation Engineer provides expertise, guidance, and maintenance of the Validation programs across biological starting materials, drug substances, and drug products manufactured at Aldevrons 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 CAPAs, leading lab investigations, risk assessments, root cause analysis, and developing implementation plans

The Essential Requirements Of The Job Include

• 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

Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role

• 10% travel to support routine inspections, audits, and customer projects

It would be a plus if you also possess previous experience in:

• Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines

Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether its a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, well accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit .

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. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: 1-202-###-#### or applyassistance@.

Seniority level

• Not Applicable

Employment type

• Full-time

Job function

• Quality Assurance

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