Principal Engineer, Fill and Finish, Technical Operations

Radiometer; Fargo (ND); On-site; USD 120,000 - 160,000; Full time

Job summary

Aldevron, a Danaher operating company, is hiring a Principal Engineer, Fill/Finish to shape our engineering strategy for Drug Product manufacturing. This on-site Fargo, ND role reports to the Sr. Manager, Automation and Process Engineering within Technical Operations.

You will drive process robustness, validation, and contamination control while mentoring engineers and leading validation and CAPA activities across the fill/finish suite.

Qualifications

• Bachelor’s degree in engineering, life sciences or related field with ~10 years of engineering experience.
• Knowledge of cGMPs, aseptic processing, contamination control, regulatory expectations (USP and EU).
• Experience with automated/semi-automated fillers, isolators, cappers, inspection systems, and secondary packaging lines.
• Experience with audits, investigations, risk assessments, and validation programs.
• Willingness to travel up to 25%, primarily domestic with some international.
• Physically able to lift up to 50 lbs and work around large equipment.

Responsibilities

• Serve as SME for aseptic fill/finish operations across Drug Substances and Drug Products from early to late phase applications.
• Provide expertise during audits and inspections.
• Drive implementation and improvements to equipment.
• Develop strategies for process robustness, validation, and contamination control.
• Mentor junior engineers and provide technical guidance.
• Lead deviations, investigations, CAPAs, and risk assessments.
• Support equipment lifecycle activities (URS, FAT/SAT, commissioning, IQ/OQ/PQ).
• Help maintain sterility assurance programs including APS, CCIT, EMPQ.
• Support PPQ strategies and validation lifecycle for filling activities.

Skills

Aseptic fill/finish operations

cGMPs knowledge

Audits and investigations

Leadership mentoring

Travel readiness

Education

Bachelor's degree in engineering or life sciences

Tools

Automated fillers

Isolators

Inspection systems

Validation programs

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 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.

Job Overview

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.

Key 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.

Essential Requirements

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.

Location & Work Arrangement

Fargo, ND – On-site role.

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.

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For more information, visit www.danaher.com. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.