CQV Engineer


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Location: Dublin

Type: Contract

Rate: Negotiable

Contact: mtreacy@asset.ie

Reference: CQV2

Updated: 24/09/2018 09:20:49


Commissioning and Validation Engineer – Sterile Fill Finish
As a lead commissioning and validation engineer you will be responsible for working within a cross functional team to ensure that the validation activities associated with formulation, filling and inspection equipment and processes meets system requirements and recognised international standards.

Major Responsibilities:

• Development of Validation Plans and 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 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, including schedule and resource planning

Equipment in scope for project includes:
• Vial filler of liquid and lyophilised vials
• Container closure integrity
• Visual inspection of finished vials


• Equipment and Systems Qualification Experience up to and including PQ
• A third level qualification in Science, Engineering or a relevant Quality discipline.
• Minimum 8 years’ experience in a similar role.

Education Requirements:

• A third level qualification in Science, Engineering or a relevant Quality discipline.

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