Principal Engineer, Fill and Finish, Technical Operations

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 Principal Engineer, Fill/Finish is responsible for building and delivering on our Fill/Finish engineering strategy to improve and grow our Drug Product manufacturing capability .  

This position reports to the Sr. Manager, Automation and Process Engineering 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: 

• Serve as subject matter expert for aseptic fill/finish operations encompassing both Drug Substances and Drug Products from early to late phase applications. Provide expertise during audits and inspections. Drive implementation and improvements to specified equipment.
• Develop engineering strategies for process robustness, process validation, and contamination control. Mentor junior engineers and provide technical guidance.
• Lead deviations, investigations, CAPAs, and risk assessments as a subject matter expert.
• Support equipment lifecycle activities (URS, FAT/SAT, commissioning, IQ/OQ/PQ). Help to maintain and improve current sterility assurance programs, including aseptic process simulations (APS), container closure integrity testing (CCIT), and environmental monitoring performance qualification (EMPQ).
• Support PPQ strategies and validation lifecycle management for filling activities.

The essential requirements of the job include: 

• Bachelors degree in engineering, life sciences or related field
• 10 years of engineering experience, with some years in a CDMO or drug product manufacturing facility, focused on fill/finish equipment
• Knowledge of cGMPs, aseptic processing, contamination control, regulatory expectations (both USP as well as EU).
• Experience with equipment such as automated and semi-automated fillers, isolators, cappers, inspection systems, and secondary packaging lines.
• Experience with audits, investigations, risk assessments, and validation programs

Travel, Motor Vehicle Record & Physical/Environment Requirements: 

• 25% ability to travel may be required, primarily domestic and some international

• Must be able to see, talk, hear, stand, walk, bend, lift up to 50 lbs, and work around large equipment

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.