Description
Our client, one of the world’s largest pharmaceutical and biotechnical companies currently require a EBEAM/ Isolator 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.CQV ISOLATOR
Responsibilities:
• Primarily SUPPORT all CQV efforts relating to EBEAM / ISOLATOR.
Lead and 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.
• Utilise 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 utilise 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 Isolator/ EBEAM 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.