Process Validation Specialist/Hybrid/Fargo, ND
Job in
Fargo, Cass County, North Dakota, 58126, USA
Listed on 2026-02-03
Listing for:
Vita Global Sciences, a Kelly Company
Full Time
position Listed on 2026-02-03
Job specializations:
-
Engineering
-
Healthcare
Job Description & How to Apply Below
Overview
Process Validation Specialist / CDMO / Hybrid / Fargo, ND
Our client is a Large Contract Development and Manufacturing Organization based in Fargo, ND, searching for a Process Validation Specialist. The ideal candidate has a strong understanding of the full process validation lifecycle, specifically for biologics products. They are looking for someone who can work independently and manage multiple process validation projects at the same time. This person will be responsible for developing Validation Master Plans, PPQ, pFMEA Risk Assessments, and Data Analysis/Trend Analysis.
Contract Duration: 6 Months with the possibility of extension
Responsibilities- Strong Understanding of Process Validation Lifecycle
- Background in Biologics Products (both Drug Substance & Drug Product for API's)
- Strong experience with PPQ, Process Characterization, pFMEA Risk Assessments, Data Analysis / Trend Analysis in Excel & JMP, Protocol Generation, Shipping Validation
- 5-10 years working in Process Development / Validation
- Ability to work independently
- Ability to manage multiple projects concurrently
Posted By: Jesse De Francesco
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