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.
- 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.
- 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.