GerTEK Project Management & Technical Services is one of Ireland’s leading Project Management and Technical Service companies. We are hiring for an experienced Validation Engineer to join our team.
- Coordination / direction and active participation in the validation and quality assurance of site equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.
- Generation/maintenance/execution of the Site Validation Master Plan.
- Generation/maintenance/execution of Project Validation Plans and schedules.
- Generation of validation protocols and final reports to cGMP standards.
- Generation of validation investigations and implementation of corrective actions.
- Participate in validation of Laboratory Equipment and Test Method Transfer
- Creation/Review/Approval of various quality documents and test data.
- Management of validation, exception event, and change control processes.
- Completing all required training before executing a task.
- Documenting all activities in line with cGMP requirements.
- Updating of validation procedures, templates and involvement in process improvements for Quality Organisation
- Performing cross training within the team and training of new team members.
- Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.
- Communicating with peers and management regarding activities in the area, including elevation of events or concerns.
Education & Key Skills
- Engineering degree and/or equivalent qualification.
- 3 years plus Validation/Quality experience in GMP manufacturing establishment ideally in moulding or assembly operations.
- 3 years plus of knowledge of cGMP and regulatory requirements relating to the
medical device industry.
- Strong communication (written and oral), presentation and troubleshooting skills required
- Effective interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
- Capable of prioritizing work and multitasking.