LSC has a fantastic opportunity for CQV Downstream Engineer to join an advanced global team in Denmark that promotes self-development, encourages collaboration, and fosters a learning environment. The company specialises in clinical & commercial manufacturing of Biotech medicines, including viral gene therapies and has built a strong reputation over the years for bringing complex and lifechanging therapies into reality. This is a chance for you to be a part of a fast-growing, multicultural company that has a compelling vision for shaping the future of medicine.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Responsible for review of all design deliverables from EPCM including drawings, datasheets, specifications and engineering lists.
- Support generation of all CQV downstream documentation - FAT wraparounds, DQ, RTM, QRA, SAT/IOC and IOQ, including final reports.
- Generate downstream bridging document, ensuring full alignment with process science (PS) in relation to supply of CPPs and CQAs.
- Point CQV person for vendor review for all DST vendor packages.
- CQV SME for all downstream systems.
- Liaise with EPCM in relation to construction readiness and a schedule for all downstream systems, perform and lead all field walkdowns for all systems.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 5 + years' CQV Downstream Equipment experience on Large Scale Projects
- SME on all downstream systems, minimum 5-10 years
- Working knowledge of ASTM E2500 / Leveraging Verification process
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 214771329 if you have any more questions about this opportunity!