Description
An experienced Commissioning and Validation Engineer is required to join a Pharmaceutical organisation based in Ireland. This is a role that will require the successful engineer to work 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.Duties and 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 and Skills Required:
• Equipment and Systems Qualification experience up to and including PQ.
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Experience of working in a similar role.
To learn more about this excellent and rare opportunity to join a prestigious Global Pharmaceutical organisation and fulfil a unique and rewarding role, please send in your current CV