Commissioning and Validation Engineer

SimoTech requires a Commissioning and Validation Engineer for a project in Leinster. Candidates must have at least 5 years prior experience in a similar role in a pharmaceutical or life sciences manufacturing environment.

Job Description

The Commissioning and Validation Engineer will be responsible for working within a cross functional team to ensure that validation activities associated with support equipment and equipment for producing Sterile Filled Syringes are in compliance with division quality system requirements and recognised international standards.

Major Responsibilities
  • Assist in development of Validation Plans and development of Installation Verification, Functional Testing and Performance Qualifications (PQs) for equipment.
  • 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.
  • Ensure that the site meets the quality requirements of its customers and applicable regulations FDA, EU & International Standards.
  • 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.
  • Assist in the implementation of any existing Validation program to ensure continued compliance to the necessary regulations.
  • Assist in deviation and exception resolution and root cause analysis.
  • Participate as required in project activities.
  • A third level qualification in Science, Engineering or a relevant Quality discipline.
  • Equipment and Systems Qualification experience up to and including PQ.
  • A third level qualification in Science, Engineering or a relevant Quality discipline.
  • Minimum 5 years experience in a similar role.
Contact us to discuss this opportunity.
All available roles require a current valid EU work permit or permission. Applications without valid work permission for the EU can not be considered.
No agencies please.