CSV Lead Engineer

SimoTech requires a Lead Computer System Validation (CSV) Engineer for a large-scale biopharmaceutical project based in Dublin. The ideal person will have experience overseeing the design, commissioning, qualification and validation of systems on transfer and upgrade projects.

Key Responsibilities
  • Design, Commissioning, Qualification and Validation documentation – drafting, reviewing and approving CSV related elements of documentation as appropriate.
  • Co-ordinate and execute CSV related commissioning, qualification and validation activities where applicable.
  • 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.
  • Understand and apply industry specific compliance standards/regulations to all Commissioning/Qualification activities.
  • 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.
  • Proactively keeping up to date with current thinking and best practice.
Qualifications
  • Degree level qualification in Science or Engineering or equivalent.
  • Experience in process automation, MES 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.
  • Experience in the implementation of a risk based validation approach as per ASTM E2500– Preferred but not required.
  • Experience with Process Control & Building Management Systems – preferably DeltaV.
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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