Danaher

Principal Engineer, Fill and Finish, Technical Operations

Danaher$110K — $130K *
Fargo, ND 58103In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering, life sciences or related field
  • 10 years of engineering experience in a CDMO or drug product manufacturing facility, focused on fill/finish equipment
  • Knowledge of cGMPs, aseptic processing, contamination control, and regulatory expectations (USP and EU)
  • Experience with automated and 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 across drug substances and products
  • Develop engineering strategies for process robustness and contamination control
  • Lead deviations, investigations, CAPAs, and risk assessments
  • Support equipment lifecycle activities including commissioning and validation
  • Maintain and improve sterility assurance programs with APS, CCIT, and EMPQ
  • Support PPQ strategies and validation lifecycle management for filling activities

Benefits

  • Comprehensive health care programs
  • Competitive paid time off
  • Variety of benefit programs contributing to life beyond the job
Full Job Description
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.

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.

About Danaher

Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. More than 275,000 Beckman Coulter systems operate in both Diagnostics and Life Sciences laboratories on seven continents. For more than 75 years, our products have been making a difference in peoples' lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and delivering trusted solutions for research and discovery.

Danaher Careers

Joining Danaher means becoming part of a global team committed to driving growth, innovation, and leadership across various industries. At Danaher, we offer more than just job opportunities; we provide a platform for professional development and personal achievement.

Work You’ll Do

At Danaher, you will engage in work that propels global industries forward through innovation and leadership. Our team at Danaher is dedicated to enhancing the company's impact on science, technology, and healthcare. We believe in fostering a culture of diversity and inclusion, where every team member’s contribution is valued.

Explore Danaher’s Career Opportunities

Whether you are looking for a full-time position, an internship, or a leadership role, Danaher offers a range of employment opportunities to help you advance your career. Our hiring process is designed to identify and attract professionals who are not only skilled but are also passionate about making a difference.

Innovate and Grow with Us

Join a team where innovation is at the heart of everything we do. Danaher’s commitment to innovation drives our leadership in the market and our ability to offer unique solutions to our clients. Here, your skills in technology, problem-solving, and creativity will be honed through challenging projects and a collaborative work environment.

Benefits and Culture

Danaher is dedicated to providing a supportive work environment where careers flourish. Our benefits package is designed to support the health, well-being, and financial security of our employees and their families. From diversity training to professional development programs, we invest in every employee's growth and well-being.

Networking and Professional Development

At Danaher, networking and professional development are part of our DNA. We encourage our employees to connect with colleagues and leaders through various networking events, training sessions, and collaborative projects. This culture of growth and learning helps every team member build a rewarding career filled with exciting new challenges and opportunities.

Join Our Team

Ready to take the next step in your career? Explore the open positions on our Danaher Careers page. Tailor your resume, prepare for your interview, and join a team that’s dedicated to making a real impact. At Danaher, your career is just the beginning of a journey filled with leadership opportunities, innovative projects, and a chance to work with some of the brightest minds in the industry.

Stay Connected

Keep up to date with the latest from Danaher by subscribing to our job alert emails. Get insights into our company culture, read about our industry-leading innovations, and learn about new job openings tailored to your interests and skills.

Danaher: Where Careers Grow

At Danaher, we are not just creating job opportunities; we are building careers that make a difference. Join us in our mission to shape the future through innovation, leadership, and growth.
Learn more about Danaher
Size
78,000 employees
Market Cap
$189 billion
Industry
Net Income
$3.6 billion
Founded
1969
5 Year Trend
+11.8%
Revenue
$22.2 billion
NASDAQ

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