CQV Engineer (Senior)


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Location: Dublin

Type: Contract

Rate: Negotiable

Contact: mtreacy@asset.ie

Reference: SNR CQV

Updated: 13/07/2018 15:12:55


• Primarily lead all C&Q efforts relating to Utilities and Equipment.
• Support QRAES (Quality Risk Assessments) for all related Systems.
• Generate all Test Matrices for related Systems, ensure TM’s include all testing requirements and are approved and under revision control.
• Review and approval of all Vendor Documentation
• Lead for all Factory Acceptance Testing
Liaise with vendors / suppliers in relation to GEP and GDP requirements for “leverage-able” test documentation
• Liaise with RV Lead to ensure all RV deliverables are executed as per Project Procedures.
• Utilize and coordinate EDMQ System for review and approval of Protocols Lead for all execution work for related Systems - all Installation Verification deliverables = Walkdowns, Tag Verification, Loop Checks, Static Set to Work (STW), Pre-Start-up Safety Review (PSSR), Dynamic Set to Work (DSTW).
• Generation of FV deliverables - Automation Checkout (ACO), Site Acceptance Test (SAT), Functional Testing, Phase and Recipe Testing
• Manage the timely closure of all CQV Punchlist items
• Liaise and utilize Engineering Change Management System (ECM)
• Review and approval of all Vendor Turnover Packages and Field Turnover Packages against the VDR and to ensure these support the Validation Requirements for the system
• Lead for Mechanical Completion acceptance and Walkdowns
• Liaise with H&S in relation to LOTO and Permit issue and control
• Prioritise qualification activities in line with the project schedules and business needs


• Prepare C&QSR’s (Commissioning Summary Reports) for executed documentation
• Ensure all the requirements for the C&Q summary reports are available and the good engineering and documentation practices have been followed throughout.
• Review all vendor and site change controls for impact to the completed testing as required.
• Liaise with QA in close-out of all C&Q deviations and exceptions.

Candidate's Must have, previous experience commissioning and qualification experience, utilities and process equipment in the pharmaceutical industry. Candidates need to have at least 5 years in a similar role.

HVACs Systems, chilled water and formulation vessel commissioning and qualification experience would make a candidate stand out.

Candidates ideally need experience from a fill finish company

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