Computerised Systems Validation Engineer
Salary: Up to £60,000 per annum
Benefits: –25 days annual leave plus 8 bank holidays
-Stakeholder pension scheme (8% employer 4% employee)
-Life assurance 3 x annual salary
-Assistance with relocation
Hours: 37.5 hours per week
Job Type: Permanent
Reports to: Validation Manager
This role is for a computerised systems validation engineer within a team that design and perform validation activities associated with new installation projects and improvements to the existing manufacturing process.
This role is responsible for authoring, executing and reporting computerised systems validation activities within the framework of cGMP and in compliance with the Global QMS requirements. Within this role, the engineer will be required to manage multiple validation projects, liaising with the project team and all associated departments on site relating to the validation objects and work is completed in a timely manner.
In addition to the above, the primary skill of the role requires the applicant to be fully conversant and trained in EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and all associated computerised system validation within the pharmaceutical environment.
- Computerised Systems Validation
- Authoring Computer Systems Validation life-cycle documents as standalone documents or to form part of an overall document for a process or set of equipment.
- Interpretation and assessment of third party supplier Functional, Hardware and Software Design Specifications, against EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and Global Quality requirements.
- Capable of devising, developing and execution, of Computer Systems Validation life-cycle protocols and reports.
- Capable of leading computerised systems validation projects in isolation or as part of larger projects.
- Capable of leading investigations into computerised systems validation failures to include devising specific technical studies and processing data.
- Capable of preparing and presenting computerised systems validation report packages to line management.
- Implementation of and compliance to EU GMP Annex 11, 21 CFR Part 11, GAMP 5 and Global Quality requirements.
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.