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:
- CSV CQV Engineer for generation in tandem with Automation of all Project Lifecycle Documents for Vendor Packaged Equipment PLC systems and Field-testing protocol generation/execution.
- Liaise with CSV Leads and Automation PM in relation to CSV portion of Project Schedule. Coordinate and assist CSV Group for Project deliverables from Design through to PPQ Stage.
- During Qualification clearly Identify and Develop with Automation the "Test Documentation" with the Automation and IT Team. Full identify full scope of all Computer System Validation Qualification efforts to be implemented for the Project, both GMP and Non-GMP Systems.
- Aligning with Automation, write Computer Systems Validation Protocols for the Automation & IT computer Systems, Support Automation Group in field execution and Final Report writing. Generate Project Change Controls for changes to Computer systems during Qualification.
- 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum 5 years CSV experience on Large Scale Projects
- CSV of both PLC and DeltaV systems, minimum 5 years
- Computer skills (Database, Access, EIDA, Spreadsheets, Word Processing, Visio, Microsoft Project)
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!