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.