CSV Engineer

SimoTech requires a CSV (Computer Systems Validation) Engineer for a large-scale biopharmaceutical site based in Dublin. The primary responsibility of this role will oversee the commissioning, qualification and validation of MES/PAS projects. Candidates must have at least 3 years’ experience in the pharmaceutical/life sciences industry.

Key Responsibilities
  • Technical SME for all CSV related activities.
  • Prepare and implement overall Validation strategy.
  • Design, Commissioning, Qualification and Validation documentation.
  • Oversee and implement CQV activities.
  • Conduct risk assessments, root cause analysis and investigations.
  • Executing DQ, FATs, SATs.
  • Ensure that all industry specific compliance standards are met.
  • Conduct risk assessments, root cause analysis and investigations.
  • Review and approve project change controls and deviations.
  • Provide coaching and mentoring to more junior member of the team.
  • Third level qualification in Science or Engineering or related discipline.
  • Minimum of 3 years relevant CSV experience in either the Biotech or Pharma industry.
  • MES/PAS experience preferably.
  • Strong technical writing and communication skills.
  • Excellent stakeholder management.
What SimoTech Can Offer
  • Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
  • Long term project opportunity.
  • SimoTech can facilitate these positions as a staff engineer or contract engineer.
  • Competitive staff or contract rates.

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