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)


Description:

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.

Competencies:

• 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