Description
Team Horizon is seeking a Validation Engineer for a 12-month contract for our client’s manufacturing facility in Sligo.
Why you should apply:
1. Exciting opportunity to join a global pharmaceutical company and join a dierse and experienced team
What you will be doing:
2. Ensure all Computerized systems are qualified in compliance with Data Integrity policies
and regulatory requirements.
3. Co-ordination / direction and active participation in the validation of site equipment,
facilities, utilities, processes and software in compliance with company policies, FDA,
European cGMP and GAMP standards.
4. Generation/maintenance of the Validation Master Plans.
5. Generation/maintenance of Project Validation Plans.
6. Generation of validation plans, protocols and final reports to cGMP standard.
7. Review / approval of all protocols and final reports.
8. Management of validation change control process.
9. Adheres to and supports all EHS & E standards, procedures and policies
What you need to apply:
10. 3rd level qualification in a relevant engineering or scientific discipline.
11. A minimum of 5-10 years’ experience in a cGMP regulated environment.
12. A good understanding of regulatory requirements.
13. Experience in Process validation (PPQ) in API or Drug product and experience with managing validation events / Non-Conformances during PPQ
14. FUE qualification essential (preferably API). Experience with working in fast paced projects. Understanding of ASTM E risk-based qualification.
15. Good understanding of Critical Process Parameters/ Non critical process parameters and their relationship with instrument calibration tolerances and selection of PPQ test criteria
16. Ability to work directly with Engineering and other stakeholders to understand validation requirements.
17. Ability to react to problems quickly during validation.