Commissioning and Validation Engineer

SimoTech requires a Commissioning and Validation Engineer for a large-scale biopharmaceutical project in Dublin. Responsible for working within a cross functional team to ensure that the validation activities associated with process equipment for vial and syringe fill finish processes meets system requirements and recognised international standards. Candidates must have a minimum of 5 years’ experience in operations/manufacturing environment in the pharmaceutical / life sciences industry.

Key Responsibilities
  • Working with the team to ensure all aspects of activity within the commissioning and Validation of equipment adhere to required policies and procedures, including safety and training.
  • To assist the development of Validation Plans and development of Installation Verification, Functional Testing and Performance Qualifications (PQs) for equipment.
  • Prepare and execute validation protocols and can complete risk assessments from a quality system perspective.
  • Assist with Engineering and external vendors regarding equipment User Requirement Specifications (URS’s), DQ.
  • Ensure that the Site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
  • To assist the implementation of any existing Validation program to ensure continued compliance to the necessary regulations.
  • To assist in deviation and exception resolution and root cause analysis.
  • To participate as required in project activities.
Qualification and Experience
  • A third level qualification in Science, Engineering or a relevant Quality discipline.
  • Minimum 5 years’ experience in a similar role in operations/manufacturing environment in the pharmaceutical / life sciences industry.
  • Equipment and Systems Qualification Experience up to and including PQ.
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.
  • Flexible working hours and location.
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