LSC has a fantastic opportunity for a CSV CQV 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:
- PLAN for Standalone QC laboratory instruments.
- Support Automation Group in field execution and Final Report writing. Lead and coordinate the APCC (Automation Project Change Control).
- In tandem with Automation, responsible for generating all Automation/CSV Project Templates. Support Design Qualification effort in relation to all CSV and Automation input for DQ and DQ Reporting.
- Attend Risk Assessments sessions, representing Automation/CSV, including Complexity/Customization, FMEA, Product Contact List (PCL) and Critical Instrument List (CIL).
- Liaising with Automation, coordinate and manage all CSV vendors, from FAT/SAT/IOQ.
- Run and coordinate Weekly CSV Meeting, reporting back to CQV PM on deliverables.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Experience with complex projects and working in or around operating facilities.
- Ability to keep work pace and meet deadlines. Good organizing and planning skills.
- Demonstrated proficiency communicating and collaborating at a variety of levels with customers, vendors, equipment suppliers and operations staff.
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 Paul O Driscoll at +353 214771329 if you have any more questions about this opportunity!