LSC has a fantastic opportunity for a CSV Automation Engineer to join an advanced global team in Denmark that promotes self-development, encourages collaboration, and fosters a learning environment. 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:
- Clarify the automation qualification strategy based on the corresponding strategy in the existing projects, focusing on the Building Management System (BMS) and Validated Data System (VDS, a GMP validated BMS system).
- Generate the needed automation Validation Plans based on the corresponding for the existing projects for the BMS/VDS systems.
- Generate and execute Automation Commissioning and Qualification test protocols for the Automation systems in scope of the project.
- Support and participate in system testing.
- Clarify discrepancies and review/approve executed test protocols.
- Secure right quality strategy related to requirement and design documents and quality activities.
- Secure a good and common structure for the CSV solutions.
- Coordinate and collaborate with CQV related to strategies, solutions, and time frames.
- Coordinate and collaborate with FDBD site SME's and end users to obtain necessary buy in.
- Comment/challenge and coordinate review of design documentation.
- Support design quality activities in relation to BMS/VDS.
- Support the automation team in test execution and final report writing.
- Based on the existing project, update and align SOP's related to project automation activities for BMS/VDS systems.
- Setup of automation activities in Kneat, the project validation execution platform.
- Support CSV activities on other Automation systems such as DeltaV/PI/Syncade/Infobatch as needed
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- 3-5+ years' experience as CSV or CQV engineer working with automation in large pharma / biotech projects.
- Experience with Aveva (Wunderware) preferred, experience with other validated automation systems a plus
- B.Sc / M.Sc. in Engineering
Note: As this is a contract opportunity you will need to hold an EU Passport to apply! Apply via this advert or contact Paul O'Driscoll at +353 214777329 if you have any more questions about this opportunity!
