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CSV Lead 1082



SimoTech requires a Lead Computer Systems Validation Engineer for a pharmaceutical project based in Cork and will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing facility. The position will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative. Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.

Key Responsibilities

  • Manage the Computer System Validation aspect of IT projects from software install to business release.
  • Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration.
  • Preparing master plans.
  • Executing, witnessing and post execution approving DQ, FATs, SATs.
  • Contribute to scheduling, tracking, reporting and achieving project deadlines.
  • Input into the core aspects of Operations, Qualification and Validation SOP’s.
  • Actively contribute to project teams.
  • Attend Departmental and Team meetings focused on CSV activities.
  • Serve as a CSV representative for internal technical group discussions.
  • Develop an understanding of the impact that project decisions have on cGMP and communicate this impact to project team.
  • Conduct and participate in risk assessments, root cause analysis and investigations.
  • Review, approve and sign off protocols, reports, project change controls and deviations.
  • Proactively highlight any issues around compliance.
  • Participate in internal and external audits and inspections where required.


  • Degree level qualification in Science or Engineering or equivalent.
  • Experience in process automation, is a distinct advantage.
  • A minimum of 5 years plus industry related experience.
  • Understanding and experience in GAMP, GDP AND cGMP environments.
  • Strong technical writing and communication skills.
  • Ability to close items to completion.
  • Ability to work with a high level of detail and to a high standard.
  • Experience with ISA S95 and S88 standards.
  • Experience of Testing GAMP Category 3, 4 & 5 systems & knowledge of CFR 21 Part11.

What SimoTech Can Offer

  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
  • Opportunity to work with large corporate clients on exciting capital projects.

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