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CSV Lead 1261

Leinster  

JOB DESCRIPTION

SimoTech require a CSV Lead to join a new project team. They will perform activities to support the computer systems commissioning and qualification and subsequent validation of those systems. The CSV Lead will be part of the start-up team responsible for the development and delivery of automated systems to enable the start-up, commissioning and qualification of a greenfield plant.



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 including preparing validation master plans and executing DQ, FATs, SATs.
  • Contribute to the scheduling, tracking, reporting, and achieving project deadlines.
  • Input into the core aspects of Operations, Qualification and Validation SOP's.
  • 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 and considering impact on cGMP based on project decisions.
  • Conduct and participate in risk assessments, root cause analysis and investigation.
  • 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.


Qualifications

  • Degree level qualification in Science or Engineering or equivalent.
  • 10+ years of CSV experience in Pharmaceuticals or Biopharmaceuticals.
  • Experience in process automation.
  • Understanding and experience in GAMP, GDP AND cGMP environments.
  • Experience with ISA S95 and S88 standards.
  • Experience of Testing GAMP Category 3, 4 & 5 systems & knowledge of CFR 21 Part11.
  • Solid organizational skills including attention to detail and multitasking skills.


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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