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.
The
Engineer II, Process Validation is responsible for leading & supporting internal and external validation projects that enable commercialization of vital new life saving medicines.
This position reports to the Process Validation Manager 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:- Design, execute, analyze, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
- Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including but not limited to process capability, trend analysis and control charts and DOE interpretation.
- Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events.
The essential requirements of the job include:- Bachelor's or master's degree in engineering with 2+ years of experience.
- Prior experience in leading deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train with a thorough understanding of the manufacturing process.
- Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
- Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments.
Travel, Motor Vehicle Record & Physical/Environment Requirements:- Ability to travel 5% of the time to support audits and client visits.
- Ability to lift, move or carry equipment up to 10 lbs.
It would be a plus if you also possess previous experience in:- Client facing roles such as prior experience in a CDMO environment
- Sterile fill-finish process and equipment qualifications
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.
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