Process Validation Specialist / Hybrid / Fargo, ND

Remote in Fargo, ND, US • Posted 30+ days ago • Updated 10 hours ago

Contract W2

On-site

Fitment

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Job Details

Skills

Contract Management
Manufacturing
API
FMEA
Risk Assessment
Data Analysis
Trend Analysis
Microsoft Excel
JMP
Shipping
Process Engineering
Management

Summary

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

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.

Dice Id: 10105282
Position Id: 860935
Posted 30+ days ago

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Process Validation Specialist / Hybrid / Fargo, ND

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