Apply in 3 Minutes: Validation Engineer

3 days ago

Galway, Ireland CREGG Full time

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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