CSV Engineer - Ireland (County Kerry)
A well-established pharmaceutical client is looking for several CSV Engineers 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 execution, so needs fully site based professionals.
Responsibilities will include:
Generation of execution of Risk Assessments, URS, DQ, RTM and IOQ protocol and IOQ Reports
P&ID Walkdowns associated with PCS panels and Construction Team
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
Strong trouble shooting experience during field execution
Familiar with LOTO, Safe Plan of Action and PSSR
Ideally Engineers have a strong automation background for troubleshooting
GMP regulations, GAMP5, 21CFR Part 11, EU Annex 11, Data Integrity requirements
With the project being primarily at execution phase, there are excellent hours on offer. If you have a strong background in CSV and are interested then please get in touch to discuss further.
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