Salary: Up to £65 per hour
Hours: 40 hours per week
Job Type: 6 month contract
Reports to: Validation Supervisor
This role is for a Validation Engineer within a team that design and perform validation activities associated with new installation projects (Equipment / Facilities / Utilities / Systems), to the existing manufacturing process and manufacturing of Intravenous products at the Thetford plant.
The Validation Engineer function will work within one of six areas in a stream approach:
- Equipment / Process systems
- Cleaning Validation
- HVAC & Cleanroom systems
The Validation Stream Leads are expected to be the primary contact and validation subject matter experts (SME) for their particular field. They are also the owners of the validated state pertaining to their streams.
It is, however, also expected that the successful candidate will be able to interact and cover, at times, within streams other than their own. Therefore, a wide range of experience is being looked for in a suitable candidate.
As part of the above, this role is responsible for authoring, executing and reporting validation activities within the framework of cGMP – Annex 11 & 15 and in compliance with Global QMS requirements.
Within this role, the engineer will be required to manage multiple validation objects, liaising with the project team and all associated departments on site relating to the validation objects and work is completed in a timely manner.
The primary skill of the role requires the applicant to have a good working knowledge of Validation requirements for Equipment / Facilities / Utilities including associated control systems. In addition a working knowledge in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and associated computerised system validation within the pharmaceutical environment.
- Equipment / Facility Qualification
- Cleaning Validation
- Process Validation
- Computerised Systems Validation
- Temperature Mapping
If you are interested in this position or would like to hear more information then please call Callum on 0208 364 9911. Alternatively you can email me on ‘firstname.lastname@example.org’.
We act as an employment business to provide temporary staff and an employment agency to provide permanent staff.