Validation Engineer

4 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 or / .
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