Job description Posted 02 September 2022

Computer Systems Validation Engineer

12 Month contract

Location: Stevenage / hybrid role

Pay rate £65.10 per hour via Umbrella (inside IR35)


To provide validation support for new processes being created in Labware Core Lab Systems for the cell and gene therapy QC Labs throughout the application lifecycle performing activities such as

• Authoring and Review of computer system validation documentation including but not limited to user requirements, user acceptance test cases, user acceptance test summary reports

• Execution of informal and formal user acceptance testing

Key Responsibilities:

• Provide Validation expertise where needed to support computer systems upgrades and enhancements

• Delivery of business components of System validation for Labware Core Lab Systems for the cell and gene therapy QC Labs

• Maintain high level of focused customer service for all business support activities.

• To prepare validation documentation to agreed standards, including contribution to and reviews of documents authored by other groups (e.g. R&D IT).

• To provide regular and appropriate updates and status reports to management

• To work with subject matter experts for a given scientific technique to document user acceptance test steps for validation of developed system process or fix.


• Competent and strong understanding of Computer System Validation

• Good understanding of FDA 21 CFR Part 11 & EudraLex Volume 4 Annex 11.

• Good understanding of ALCOA+

• Competent with systems (experience with Labware is preferable)

• Good at working in a team

• Good at working independently