Process Validation Engineer II

Company: Aldevron
Location: Fargo
Posted on: April 25, 2025

Job Description:

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 Supervisor 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. The essential requirements of the job include:
  • Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) and 2+ years of experience in process development and/or technology transfer OR Associate degree in Engineering Technology or related field with 4+ 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. It would be a plus if you also possess previous experience in:
    • 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. This job is also eligible for bonus/incentive pay. We offer a comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law. 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 . 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. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at to request accommodation.

Keywords: Aldevron, Fargo , Process Validation Engineer II, Engineering , Fargo, North Dakota