An exciting opportunity has arisen, within a biopharmaceutical client in Dublin South. This is a contractor role for a Senior CQV Engineer.
If you are interested in this job apply below. I also have more senior or indeed junior roles within QC, QA, QP, Validation, CQV, PM and other areas of pharmaceutical, medical device, and biologics companies. Send me an email or simply your CV to schedule a confidential chat (014744692) - to andrius "at" sigmar.ie
- 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
- rioritise 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.
- Previous commissioning and qualification experience, utilities and process equipment in the pharmaceutical industry.
- At least 3 years in a similar role.
- HVACs Systems, chilled water and formulation vessel commissioning and qualification experience is a distinct advantage.
- Ideally need experience from a fill finish company
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