Computer Systems Validation Engineer Role Meath

CSV Engineer

  • Posted Jul 18, 2022
  • Meath
  • Contract
  • BBBH25474

LSC have a great contract opportunity for an CSV Engineer to join a leading biotech company based in Meath.

If you have bachelor's Degree in Engineering, Information Systems, Computer Science, or the Life Sciences and are ready for your next challenge, this could be the perfect project for you!

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

  • Generate/ update, execute, review, and approve Computer System Validation (CSV) deliverables in line with the Process Automation Remediation Plan delivery.
  • Investigate and trouble shoot problems which occur to determine solutions or recommendations for improvements or change.
  • Work with the system owners and Quality team to ensure that the appropriate Quality standards are applied for all CSV documents and deliverables, consistent with best practice and internal Quality Standards and expectations.
  • Provide technical support for the development of electronic data review procedures
  • Actively manage the execution of all CSV testing with right first-time approach.
  • Ensure that any changes in detailed timelines are escalated in a timely manner so that impacts can be proactively assessed and KPI's maintained.

ABOUT YOU - ARE YOUR SKILLS A MATCH?

  • At least 2 years' experience in the planning, document generation, support or execution of CSV activities in a biologic drug substance manufacturing plant.
  • A thorough knowledge of regulatory requirements associated with computer systems including EU GMP Annex 11, 21 CFR Part 11 is required.
  • Experience in PLC/SCADA/DCS systems

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 021 4777 329 if you have any more questions about this opportunity!

This could be the perfect project for you! Apply online and we’ll be in contact shortly

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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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