Process Validation Specialist​/Hybrid​/Fargo, ND

Process Validation Specialist / Hybrid / Fargo, ND

Vita Global Sciences, a Kelly Company

This range is provided by Vita Global Sciences, a Kelly Company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $100.00/hr

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.

• Strong understanding of the full process validation lifecycle (biologics: Drug Substance & Drug Product).
• Develop Validation Master Plans, PPQ, pFMEA Risk Assessments, and Data Analysis/Trend Analysis.
• Work independently and manage multiple process validation projects concurrently.
• Prepare and review validation documentation in accordance with regulatory and client requirements.

• Strong understanding of Process Validation Lifecycle.
• Background in Biologics Products (Drug Substance & Drug Product).
• Experience with PPQ, Process Characterization, pFMEA Risk Assessments, Data Analysis/Trend Analysis in Excel & JMP, and Protocol Generation.

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

Contract Duration: 6 Months with the possibility of extension.

Base pay range: $50.00/hr - $100.00/hr

Posted By: Jesse De Francesco