CREGG are now recruiting for a Validation Engineer. This is a fantastic opportunity to join a world leading Medical Device company in Co. Galway, working as a Validation Engineer working on the latest projects and state of the art equipment. This role offers great working flexibility with great career progression opportunities.
The role:
Responsibilities include executing equipment and process validations with the validation project team (IQ OQ PQ) and assigning validation activities to the validation project team.
Key Duties:
* Prepare validation protocols for the Equipment Engineering group and execute these protocols to ensure sign-off is obtained at each stage.
* Carry out and execute process and equipment validations.
* Introduce new equipment to the site.
* Create and execute protocols and reports, review Equipment Function Specs, and provide direction and support on validation strategy and plans.
* Work with the Quality department to ensure equipment validations are in line with global and site validation standards.
* Ensure regulatory compliance with global software validation requirements.
* Ensure the Computerised system validation procedure is up to date and maintained.
* Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
* Provide software validation/compliance guidance and training to staff across various functions as required.
* Develop and enhance cross-functional team relationships and work cross-functionally to identify and resolve technical and organisational issues.
* Ensure best validation practices are employed by the Equipment Engineering Group to maximise effectiveness and minimise non-value added work.
* Communicate effectively and efficiently with cross-functional teams on project tasks.
* Actively pursue continuous improvement.
* Complete project deliverables and monitor project schedule and scope changes to assure the team can meet delivery requirements for related projects.
* Generate quotations, concepts, and business cases for new and upgrade software systems.
* Project management of sustaining projects.
* Manage and mentor contract employees.
Requirements:
* Level 8 qualification in Science/Engineering or Quality.
* 3+ years’ experience in a Validation role within a medical device, biotechnology, or pharmaceutical manufacturing organization or equivalent.
* Proven track record in validations within a manufacturing environment.
For more information on this role, please contact Gary Keane at garykeane@cregg.ie or 061-363318 / 086-1030418.
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