Overview
Remote
On Site
Contract - W2
Skills
Contract Management
Manufacturing
FMEA
Risk Assessment
Data Analysis
Trend Analysis
Microsoft Excel
JMP
Process Engineering
Management
Job Details
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
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)
- Strong experience with PPQ, Process Characterization, pFMEA Risk Assessments, Data Analysis / Trend Analysis in Excel & JMP, Protocol Generation
- 5-10 years working in Process Development / Validation
- Ability to work independently
- Ability to manage multiple projects concurrently
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.