Commissioning & Validation Engineer (Senior)

Job type:
Start date:
12 Months
Real Staffing
Published at:
flag_no Ireland
Project ID:

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(CQV) 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


* 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.