Manufacturing Validation Engineer – Galway (Hybrid)
CREGG are now recruiting for Manufacturing Validation Engineer. Hybrid role. 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
Responsible for executing equipment and process validations with the validation project team. IQ OQ PQ.
Responsible for the assignment of validation activities to the validation project team.
Manage all aspects of Process, Equipment & computerised system validation for any software systems used in the manufacture of medical devices.
Key Duties
Prepare validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
Carry out and execute process and equipment validations.
Introduction of new equipment to site.
Creates and executes protocols and reports, reviews Equipment Function Spec’s and provides direction and support on validation strategy and plans.
Work with Quality department to ensure equipment validations are in line with global & Site validation standards.
Ensure regulatory compliance with global software validation requirements.
Ensure Computerised system validation procedure(s) is (are) kept up to date and maintained.
Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment.
Provides software validation/compliance guidance and training to staff across various functions as required.
Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organisational issues.
Ensure best validation practices are employed by the Equipment Engineering Group so as to maximise effectiveness and minimise non-value added work.
Communicates effectively & efficiently with cross-functional teams on project tasks.
Actively pursues continuous improvement.
Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects.
Generates quotations, concepts and business cases for new and upgrade software systems.
Project management of sustaining projects.
Manages & mentors contract employees.
Requirements
Level 8 qualification in Science/Engineering or Quality.
2+ years’ experience in a Manufacturing/ Validation role within medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
Proven track record in validations within manufacturing environment.
Process / Equipment IQOQPQ execution.
For more info on this role feel free to get in touch with Gary Keane (emailprotected) 061-363318 / 086-1030418
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