Process Validation Specialist / Hybrid / Fargo, ND

Process Validation Specialist / CDMO / Hybrid / Fargo, ND

Our client is 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

Required Skills & Experience

• 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

Desired Skills & Experience

• 5-10 years working in Process Development / Validation
• Ability to work independently
• Ability to manage multiple projects concurrently