Role: CSV Engineer
Contract: This is a 12 month hourly rate contract with the opportunity to extend.
You will be responsible for the Computer Systems Validation, including but not limited to SOPs revisions, periodic reviews, validation master plans and compliance.
In this role you will also have cross site responsibility to develop a computer system validation approach for manufacturing systems, utility systems, laboratory and process analytical technology systems.
This client is under massive expansion and is fast becoming one of the world's leading biologics companies, they are working on developing the first allogeneic stem cell therapy to receive central marketing approval in Europe. The product offers a new treatment option for patients who do not respond to current available therapies.
Day to day responsibilities:
- Development of standards operating procedures and work instruction. - Ensure Data Integrity and validation program meets requirements of FDA (21 CFR 820 and 21 CFR 11) and EU Volume 4 Annex 11
- Write and Execute IQ/OQ/PQ according to cGMP and site procedures - Support ongoing validated state of systems
- Provide internal support to the Engineering Leads or Equipment Qualification Lead
- Develop system documentation (test plans and strategies, other SDLC documentation) in support of validation activities.
If you are interested in this role please apply below with an updated CV. No CV ready? Want to hear more? Please feel free to reach out for more information.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales