What are the responsibilities and job description for the Senior Validation Engineer position at Katalyst Healthcares and Lifesciences?
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
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.