Description
(CQV) Commissioning and Validation EngineerAs a commissioning and validation engineer you will be 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.
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
Experience/Background
* 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.
Education Requirements
* A third level qualification in Science, Engineering or a relevant Quality discipline.