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