This is an exciting opportunity to work with a rapidly growing pharmaceutical company that is looking for a Senior Validation Engineer to join their team. This company is dedicated to developing treatments to help advance patient care worldwide! Ready to take your passion for technology and science to higher levels?
- Support Validation all validation activities for commercial manufacturing.
- Sterilization of process equipment including autoclaves, Process SIP
- Qualify Computerized and Automated systems
- Support computerized systems within a laboratory setting
- Collaborate with QA on development of CSV SOPs, cleaning, process.
- Review: Validation Protocols, system classification
- Collaborate with IT and support GxP operations
- Manage re-qualification schedules
- Bachelor's in engineering and 5+years of relevant experience in the pharmaceutical industry
- GxP with heavy knowledge on GMP
- Has worked with 21CFR Parts 11,210, 211, ad 820.
- Annex 1, EU Annex 11, ISPE, and PDA
- Experience with tools such as Ellab
- Ability to work in numerous Validation areas
- Experience with automation validation within the pharma industry