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