Overview
On Site
Full Time
Skills
Master Data Management
GMP
Data Collection
Process Engineering
Good Manufacturing Practice
MES
LIMS
Communication
Documentation
Job Details
Roles & Responsibilities :
- Develop and execute validation strategies
- Lead Process Validation & PPQ activities
- Perform C&Q for equipment, utilities, and facility systems
- Run risk and gap assessments
- Maintain equipment master data and support change controls
- Execute floor-level validation in GMP cleanrooms
- Coordinate sampling and data collection
- Support recipe authoring, data trending, and automation needs
- Train and guide cross-functional teams
- Bachelor's in Engineering
- 5+ years in biopharma validation/process engineering
- Strong process validation & equipment qualification experience
- cGMP, FDA/EMA, ICH Q7-Q10 knowledge
- MES, automation, LIMS exposure
- Cleanroom and hands-on lab skills
- Strong communication & documentation abilities
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