Computer Systems Validation Specialist
We are currently looking for a CSV Specialist to join a leading Biopharmaceutical company based in Wiltshire. As the CSV Specialist you will be responsible for re-qualification of equipment, facilities and utilities. You will carry out computer validation, cleaning validation and process validation.
Duties and Responsibilities
- Manage and execute validation activities associated with the GMP compliance of computerised and software systems. You will be responsible for ensuring that they are qualified and fit for use.
- You will ensure that the commercial risks associated with disaster recovery and data life cycle compatibility are assessed. You will be hands on and will work on various projects at one time.
- Generation, review and execution of validation protocols will be among your duties.
- You will have an input into CAPEX projects where there is computerised content. You will ensure they are designed appropriately and qualified to ensure effective and GMP compliant.
- As the CSV Specialist you will lead and execute CSV validation activities of computerised systems and equipment. You will also minimise business risk associate with processing and storage of data.
Education and Experience
We are looking to identify the following skills and experience in your profile to be successful for this position:
- BSc or MSc in an Engineering, Scientific or IT related discipline is essential.
- Proven industry experience in generation, execution and review of validation protocols. Experience of validation life cycle activities for computerised systems is also essential.
- We are looking to identify proven experience working with a GMP quality system and working with product serialisation qualification.
- Practical experience within a biopharmaceutical company would be highly beneficial to your application.
- It is essential for this role that you have an understanding of computerised systems including PLCs, SCADA, lab databases and layered software used in a GXP environment.
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 Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales