Validation Engineer
Job Type | Permanent |
Area | Sligo, Ireland |
Sector | EngineeringQuality |
Start Date | |
Advertiser | Ashling Guthrie |
Job Ref | #3268 |
Job Views | 298 |
- Description
Team Horizon is seeking a Validation Engineer on a permanent basis for our client’s manufacturing facility in the North West.
Why you should apply:
- You will get the opportunity to coordinate, implement and actively participate in the site Validation Program and general Technical Operations activities
What you will be doing:
- Coordination / direction and active participation in the validation of site Facility, 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, Project Validation Plans and schedules
- Generation of validation protocols and final reports to cGMP standards.
- Generation of validation investigations and implementation of corrective actions.
- Creation, review and approval of various quality documents and test data.
- Management of validation exception events and change control processes.
- Maintenance and tracking of validation equipment, if applicable.
- 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.
What you need to apply:
- Qualification and/or degree in engineering or scientific discipline.
- 3 years plus validation experience in pharmaceutical, diagnostics or medical device industry
- 3 years plus of knowledge of cGMP and regulatory requirements relating to pharmaceutical, diagnostics or medical device industry.
- Strong communication (written and oral), presentation and troubleshooting skills required.
- Effective interpersonal and organizational skills