Description
Our client, one of the world`s largest pharmaceutical and biotechnical companies currently require a Filling and filtration CQV Engineer to work in the commissioning stage of their prestigious ?200 million CAPEX project in Ireland. This position is starting as soon as possible and will be for 6 months.FILLING/ FILTRATION
Responsibilities:
- Primarily SUPPORT all CQV efforts relating to FILLING AND FILTRATION WORKSTREAM.
Coordinate all Test Matrices for related Systems, ensure TM`s include all testing requirements and are approved and under revision control.
- Liaise with Document Preparation Lead in relation to all Document Deliverables and Approvals, the output of Documents will be controlled by the Document Generation Tracker, which will generate Milestones and Durations, of which, the Lead will be measured against.
- Lead and coordinate Verification Design deliverables (Enhanced Design Review / Design Qualification)
- Review and approval of all Vendor Documentation
- Lead for all Factory Acceptance Testing
- Liaise with Document Preparation Lead in relation to producing Protocols (FAT/IV/SAT/FV).
- 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
-Liaise with Master Project Database Lead to ensure all A&E and Vendor Engineering Lists are loaded and correct within Database Ensure valued input into CQV Schedule and Milestones
-- Assist where applicable in Quality Audits for all vendors / suppliers
-- Utilize and coordinate EDMQ System for review and approval of Protocols Lead for all execution work for related Systems - all IV deliverables = Walkdowns, Tag Verification, Loop Checks, Static Set to Work (STW), Pre-Start-up Safety Review (PSSR), Dynamic Set to Work (DSTW).
- Lead for all FV deliverables = Start-up, De-bugging, Automation Checkout (ACO), Site Acceptance Test (SAT), 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 Responsibilities:
- Prepare CSR`s (Commissioning Summary Reports) for executed documentation
- Ensure all the requirements for the IOQ 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 CQV deviations and exceptions
- Generate Project specific SOP`s / other documentation as applicable
- Support CQV and QA programmes as required
Requirements:
-Applicants will have previous experience in the commissioning and Validation of Filling/ Filtration equipment in a pharmaceutical environment
-Applicants will have a relevant Qualification such as degree.
This is a truly excellent opportunity to work on a prestigious project at this pivotal stage as part of a large Engineering team.
Please apply now or get in contact for further information.