Principal Engineer, Fill and Finish, Technical Operations

Socket.dev; Fargo (ND); On-site; USD 120,000 - 180,000; Full time

Job summary

Aldevron in Fargo, ND seeks a Principal Engineer, Fill/Finish to build and deliver our engineering strategy for drug product manufacturing, improving capability and reliability.

You will serve as SME for aseptic fill/finish operations across Drug Substances and Drug Products, lead deviations, CAPAs, and risk assessments, and mentor engineers while supporting validation and PPQ activities. This is a on-site role with travel as needed.

Qualifications

• Bachelor's degree in engineering, life sciences or related field.
• 10 years of engineering experience, with CDMO/drug product manufacturing experience focused on fill/finish equipment.
• 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

Responsibilities

• Serve as subject matter expert for aseptic fill/finish operations spanning Drug Substances and Drug Products from early to late phase applications.
• Provide expertise during audits and inspections and drive implementation and improvements to specified equipment.
• Develop engineering strategies for process robustness, validation, and contamination control; mentor junior engineers.
• Lead deviations, investigations, CAPAs, and risk assessments as an SME.
• Support PPQ strategies and validation lifecycle management for filling activities.

Skills

Aseptic fill/finish expert

Process validation

Regulatory knowledge USP/EU

Audits & investigations

CAPA leadership

Fill/finish equipment knowledge

Education

Bachelor's degree in engineering or life sciences

Tools

Filler equipment (auto/semi-auto)

Isolators and inspection systems

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

AtAldevron, 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. Andby harnessingDanaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

AtAldevron, 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/Finishis responsibleforbuilding and delivering on our Fill/Finish engineering strategy to improve and grow our Drug Product manufacturing capability .

This positionreports to theSr. Manager, Automation and Process Engineeringandis part of theTechnical Operations department located in Fargo, NDand willbeanon-siterole.

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 domesticand 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.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s 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 www.danaher.com.

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.

For candidates who are based outside of New York City or who are applying for roles outside of New York City, for more information about conditions of any job offer please click 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:1-202-419-7762 or [e-mail].