Process Validation Engineer 1
Aldevron is an industry pioneer with a core competency in manufacturing for gene and cell therapy. We supply high-quality plasmid DNA, mRNA and proteins to our clients, who are breaking new ground on the world’s most important and challenging solutions to benefit us all. We're looking for innovative, forward-thinking individuals who share our goals of advancing science and making an impact on the world.
Aldevron is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
This position is part of the Validation Department located in Fargo, ND and will be an on-site position,. At Aldevron, we combine best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide.
Job Summary
The role of the Process Validation Engineer 1 will be to support internal and external Process Validation and Robustness activities with projects focused on understanding and reducing process variability to improve product quality, cost, and process efficiency. Additional responsibilities include supporting Cleaning Validation and Facility Environmental Monitoring Qualifications to ensure the production environment is compliant with regulatory requirements.
Responsibilities:
- Work collaboratively to design, conduct, and report findings on experiments characterizing new or changed manufacturing processes and new equipment or technology.
- Support continuous improvement projects addressing process variability, efficiency, product cost and data analysis.
- Compile, maintain and analyze critical data supporting R&D, engineering, and validation work.
- Execute and/or coordinate execution of process, cleaning, shipping, and continued process verification activities.
- Write and review validation documents related to facilities, cleaning or process validation systems comprising check for compliance with corporate standards, regulatory requirements, and technical expertise
Qualifications:
- B.A. or B.S. in Biology, Biochemistry, Engineering or related science
- 0-3 years' experience in GMP biologics manufacturing
- Experience with Cleaning Validation, Media Fill Simulation and/or environmental monitoring programs is a plus.
- Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations, and validation procedures and practices.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.