Computer Systems Validation Engineer Role Hillerød, Hillerød Municipality

CSV Automation Engineer

  • Posted Feb 6, 2024
  • Hillerød, Hillerød Municipality
  • Contract
  • BBBH27283

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!

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The benefits of contracting with LSC

  • Partners to the world’s top Life Science companies we offer you the best contract opportunities in the industry
  • 95% of LSC contracts are renewed letting you choose contracting as a long term career option
  • LSC’s Consultant Success Programme focuses on skills development & on-site support to help you achieve your career goals!

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