Contact: Caroline Kingston
Lead Validation Engineer – Contract
Our client, a medical device company in Clare are currently looking to recruit Lead Validation Engineer for their site on a contract basis.
- Lead a Team of Validation Engineers engaged in the Qualification of a new manufacturing facility and the associated manufacturing equipment and laboratory test equipment. The new facility will be qualified for the manufacture of a new range of diagnostic reagent products.
- Responsible for the Project Validation Team and for the Writing, Reviewing, Approving and Execution of Validation Protocols and Reports for Equipment, Utilities, Processes, Cleaning, Test Methods, Temperature Mapping and Equipment Software.
- Ensure compliance to all relevant global and local quality and validation procedures/standards.
- Prepare plans for Project Validation activities and Monitor progress versus plan using Visual Project Management and Visual Daily Management.
- Participate in the preparation of User Requirement Specifications to ensure that they comply with Validation and GMP requirements as required
- Represent Validation at both internal and external audits.
- Co-ordinate/Supervise Contractor Qualification activities
- Administer Validation files and ensure that Validation Logging System Database is maintained, tracking Validations and Validation Files and ensuring full record accessibility.
Third level degree in science or engineering
7 years relevant experience in a GMP/FDA/IMB regulated environment.
Experience of formal regulatory audits (e.g. FDA/IMB) and
Good working knowledge of statistics, desirable.
An existing working permit for Ireland
For further information on this Lead Validation Engineer Contract role in Clare please contact Caroline Kingston on 0868395531 / firstname.lastname@example.org
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