LSC have a great contract opportunity for a Validation Engineer to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease.
If you have minimum 5 years process equipment C&Q/ Validation experience on Large Scale Projects or commercial operations and are ready for your next challenge this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Managing the workload and providing coaching for a team of Validation Engineers within the assigned area working on.
- Aligning new facility introduction with Validation approach across Carlow site and author and owner for project VMP
- CQV approver for C&Q and developing Validation strategy documents and project plans and procedures
- Acting as Validation Lead for team of site representatives as system owners for PQ/ Validation
- Factory/Site Acceptance Test - Attendance, hands-on support, and C&Q Oversight for assigned process equipment
- Working with the C&Q Lead to ensure consolidated & compliant approach to C&Q and readiness for CQV crossover into Validation/ PQ executions
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
- Experience with liaising with other departments - Engineering, Automation, Technical, Operations, EHS and QA.
- Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Sarah Ninan at +353 21 4771 329 if you have any more questions about this opportunity!