My client is a large pharmaceutical manufacturer, with 3200 people employed across 11 sites, 6 of which are based in Ireland. We are currently recruiting a Validation Engineer to join the team based in Co Cavan.
- The Validation Engineer will be part of the QA Team reporting to the CAPA & Validation Manager.
- Responsible for the creation of validation packages and review of all validation protocols and packages.
- Responsible for the management of the plant consumables program.
- This function has the responsibility for reviewing all SOP’s for any job task they may carry out and ensure they fully understands and adheres to the SOP.
- Manage and co-ordinate the Validation Change Control System, Validation Master Plan and associated schedule and all related documentation.
- Lead the Validation Review Board, Responsible for ensuring all VRB members are trained in accordance to Validation Policies and Procedures.
- Support the CAPA and Quality Metrics programme as required.
- Conduct compliance audits and walk-downs and complete necessary follow-up reports.
- Support QA IT Systems (M-FILES) through which Validation Change Control is documented. This also involves the development and support of plant SME’s and general users.
- Support QA team with internal and external audits (including pre-audit preparation) surrounding the validation and approved consumables processes
- Bachelor’s Degree in Pharmaceutical Science, Food Science, Dairy Science or related Engineering qualifications. Food Microbiology or Food Chemistry would be desirable however, not essential.
- It is an advantage to have knowledge on Validation and CAPA Policies or FDA regulations in relation to validation.
- Food Engineering, thermal heat processing and fluid flow are advantageous.
- Knowledge of Validation preferred.
- Project Management Skills or experience with Project Management is essential.