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

AtAldevron one ofDanahers15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.

Youll thrive in a culture of belonging where you and your unique viewpoint matter. Andby harnessingDanahers 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 youll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise an unwavering commitment to quality and a collaborative spirit to drive progress. Whether youre 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 potentialone discovery at a time.

Learn about theDanaher Business Systemwhich 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

Aldevrona 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 atDanaher Benefits Info.