Overview
The Role
In the Validation Engineer role, you will be required to support new product introductions, equipment qualification and the site requalification program. The Validation Engineer has a key role in ensuring the on-going validation and compliance of existing and new equipment, systems and processes.
Job Responsibilities
1. Designing, executing and reporting on PV/Process Performance Qualifications.
2. Designing, executing and reporting on validation studies for equipment, systems and processes.
3. Ensuring validation studies are managed in conjunction with all required standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.)
4. Providing technical interpretation and guidance of current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation and depyrogenation
5. Ensuring that the validation status of equipment and systems are in compliance with cGMP at all times
6. Maintaining validation documentation through the validation lifecycle
7. Participation in external regulatory inspections
8. Support Site Change Control process
Skills
9. Capable of troubleshooting validation issues associated with projects, process development etc.
10. Competent technical knowledge of pharmaceutical plants.
11. Previous validation/product development experience would be highly advantageous for the role.
12. Knowledge of Process Validation regulations, current process validation and technical transfer industry practices, and experience of interpretation and application of guidelines and regulations.
13. Knowledge of requirements for of GAMP, ISPE Baseline guides.
14. Knowledge of steam and dry heat validation publications such as AAMI/ANSI, PDA and ISO guidelines.
15. Full understanding of relevant quality and compliance regulations
16. Able to execute projects to plan.
17. Good knowledge of quality management systems.
18. Good communication skills at organisation, team and individual levels.
19. Ability to use MS Project and SPC packages an advantage
20. Understands KPI's for the site.
EET
If you would like to discuss this role in confidence, contact Harleen Tora/