Computer Systems Validation Engineer (CSV)

SimoTech requires an experienced Computer Systems Validation Engineer (CSV) for a Biopharmaceutical project in Dublin. Ideally candidates should have at least 2 years’ experience with CSV in support of Biologics/Pharma manufacturing operations.

Responsibilities
  • Creating and executing validation documents in accordance with cGMP regulatory requirements, the Computer System Validation Master/Project Plan, Policies, Procedures to ensure robust tested systems, which are fit for use.
  • Verify that all tests have been correctly documented in compliance with the GDP.
  • Retire the Global biologics laboratory (GBL) system CSV related documents where systems have been removed from the GBL.
  • Providing value added support and constructive comment on CSV operational procedures.
  • Liaising with IT and equipment suppliers to identify data migration options for the GBL equipment.
  • Work with Quality assurance, quality control and Information technology to achieve the project timelines set.
Qualifications & Experience
  • 2 years’ experience with CSV in support of Biologics/Pharma manufacturing operations.
  • Bachelors or Master’s Degree in Engineering, Information Systems, Computer Science, or the Life Sciences.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.