CSV Engineer

SimoTech require a number of experienced CSV Engineers at all levels for an exciting greenfield Biotechnology project based in North Leinster, Ireland. Candidates must have a minimum of 3 years’ experience as a CSV Engineer within Pharmaceutical or Biotechnology project environments.

Key Responsibilities
  • Support department activities, including but not limited to the preparation of Validation/Qualification plans and strategies, risk assessments, URS, Traceability Matrix, testing, data migration, SOPs and Change Controls.
  • Ensure that the computerised systems are in full compliance with both regulatory requirements and with company policies and procedures.
  • Support the resolution of deviations and/or errors and provide quality guidance on GxP regulatory requirements.
Qualifications
  • 3rd level Science / Engineering degree required.
  • Minimum of 3 years relevant CSV experience in either the Biotech or Pharma industry.
  • Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11 is required.
  • Strong knowledge of computerised system development life cycle.
  • Experience of coordination of quality documentation and qualification/validation documentation.
  • 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.
  • 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 projects.
  • Flexible working hours and location.

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