Principal Engineer, Fill and Finish, Technical Operations

Danaher Corporation•Fargo, ND

8d•Onsite

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.

Requirements

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

Responsibilities

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.