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. 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:
- Clarify the automation qualification strategy based on the corresponding strategy in the sister projects.
- Generate any needed automation Validation Plans based on the corresponding for the sister projects.
- Generate and execute Automation Commissioning and Qualification test protocols for the Automation systems in scope of the project (e.g., DeltaV, Syncade, PI, Infobatch)
- 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 automation.
- Support the automation team in test execution and final report writing.
- Based on the sister project, update and align SOP's related to project automation activities
- Setup of automation activities in Kneat, the project validation execution platform.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum 5 years CSV experience on Large Scale Pharma/Biotech Projects
- Experience with DCS systems, preferably Emerson's Delta V system
- Solid process understanding combined with automation understanding
- Experience from the pharmaceutical or biotechnology industry.
- Knowledge of batch processes, GMP, GAMP and the S88 standard.
- Having a great sense of structure and coordination.
- Great positive energy and courage to empower and inspire others.
- Communication skills is a must.
- Having a go-do attitude and ability to navigate in a complex project setting.
Note: This role is based in Denmark. Apply via this advert or contact Paul O'Driscoll at +353 214771329 if you have any more questions about this opportunity!