Senior CQV Engineer
SimoTech requires an experienced CQV Engineer for a project in Dublin. Candidates must have at least 5 years experience in Equipment and Systems Qualification in the pharmaceutical sector.
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.
- 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
- 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.