Senior Engineer, Process Validation
About this role
About the Role Aldevron, a Danaher operating company, is seeking a Senior Engineer, Process Validation to lead and support internal and external validation projects that enable commercialization of vital new medicines. This role reports to the Process Validation Manager in the Technical Operations Department and is based in Fargo, ND with remote work options. What You'll Do
- Design, execute, and summarize deliverables across the three stages of process validation for starting materials, drug substance and drug product, aligning with FDA guidance, EU GMP Annex 15, and lifecycle approach.
- Lead planning, execution, and lifecycle management of sterile fill-finish validation programs for aseptic manufacturing (sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity, plus packaging and shipping).
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