CSV Lead

SimoTech are looking to hire a CSV (Computer Systems Validation) Lead. This role will be based on one of our projects with a start-up Biotechnology site in Dublin. The primary responsibility of this role will oversee the commissioning, qualification and validation of OEM Equipment and the DCS system.

  • 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.
  • Manage all scheduling & reporting in line with project timelines.
  • Develop strategic relations with relevant stakeholders.
  • 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.
Qualification and Requirements
  • Third level qualification in Science or Engineering or related discipline.
  • 5yrs experience in batch manufacturing would be an advantage.
  • Strong technical writing and communication skills.
  • 5yrs plus experience in Process Automation preferably with DeltaV.
  • Excellent stakeholder management.
Only Candidates eligible for work permits for Ireland/EU can be considered for this role.