Cqv Engineer (27880dl)

Independent Solutions

Dublin South

Job Summary & Responsibilities. Job Description Commissioning and Validation Engineer. As 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. Requirements. 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. This job originally appeared on RecruitIreland.com.

2137 days ago