Validation Engineer
Cregg Recruitment are currently hiring a Validation Engineer to work in leading manufacturing company in Galway for more information, call Stephen Coen 0861030418 Email stephencoen@cregg.ie.
Key Activities of the Role:
- Prepare software validation protocols for the Equipment Engineering group. Execute these protocols and ensure sign-off is obtained at each stage.
- Review Equipment Function specs and provides direction and support on validation strategy and plans.
- Work with the 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) are kept 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 enhances cross-functional team relationships and work cross-functionally to identify and resolve technical and organisational issues.
- Ensure the Equipment Engineering Group employs best validation practices to maximise effectiveness and minimise non-value-added work.
- Communicate 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 the team can meet delivery requirements for related projects.
- Generate quotations, concepts and business cases for new and upgraded software systems.
- Take part in or lead sustaining projects to support business goals and objectives.
Qualifications and Experience:
- NFQ Level 8 qualification in a STEM discipline.
- Minimum of 3-5 years experience in a Validation role within a medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.
- Proven track record and performance executing validation activity independently or as part of a team in multiple areas.
- Availability to travel as required.
- Ability to support weekend work as required
