CSV Engineer

Job Title: CSV Engineer

Location: North East (United Kingdom)

Employment Type: Contract

A well-established pharmaceutical client is looking for a CSV Engineer to assist with their ongoing project. This will be a 6 month initial project, with the total workload expected to run for 9-12 months. The role is heavily focused on software validation (Delta V), and needs a fully site based professional.

Responsibilities will include:

• Generation of execution of Risk Assessments, URS, DQ, RTM and IOQ protocol and IOQ Reports
• P&ID Walkdowns
• Review of Vendor FAT / SAT documentation and vendor TTOPs
• Execution of systems with PCS interface
• Vendor Management during SAT execution, witnessing and signing SAT documentation on behalf of client
• Raising of deviations through to their resolution and closure of deviation

Technical Requirements:

• Strong hands-on field execution experience from start-up / energization to shakedown and testing
• Delta V
• Strong automation background for troubleshooting
• Ideally experience with programming / coding
• Strong trouble shooting experience during field execution
• Familiar with LOTO, Safe Plan of Action and PSSR
• GMP regulations, GAMP5, 21CFR Part 11, EU Annex 11, Data Integrity requirements

If you have a strong background in Validation and Automation, then please get in touch to discuss further.