Engineer II, Process Validation
About The Position
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences. Aldevron is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health. The Process Validation Engineer II is part of the Technical Operations Department located in Fargo, ND and will be on-site. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Process Validation team and report to the Process Validation Manager responsible for leading & supporting internal and external validation projects. In this role, you will have the opportunity to: Develop and review validation documents for facilities, equipment, and processes. Ensure all documents comply with corporate standards and regulatory requirements. Collaborate on experiments for new or modified manufacturing processes and equipment. Analyze critical data and provide informed recommendations. Support all phases of the validation life cycle, including research, development, and continuous monitoring.
Requirements
- Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) and 4+ years of experience in process development and/or technology transfer OR Associate degree in Engineering Technology or related field with 6+ years of process development experience in a life sciences company
- Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
Nice To Haves
- Authoring, executing, and summarizing process validation lifecycle documents for stages 1, 2, and 3.
- Technical writing involving quality investigations, root cause analysis, and risk assessment.
Responsibilities
- Develop and review validation documents for facilities, equipment, and processes.
- Ensure all documents comply with corporate standards and regulatory requirements.
- Collaborate on experiments for new or modified manufacturing processes and equipment.
- Analyze critical data and provide informed recommendations.
- Support all phases of the validation life cycle, including research, development, and continuous monitoring.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
