SimoTech requires an experienced CQV Engineer for a packaging support role for a Bio-Pharmaceutical project in Leinster. Candidates should have previous experience in a similar role in Biotechnology or Life Sciences manufacturing.
- Primarily involved in all CQV efforts relating to Packaging.
- Complete Quality Risk Assessments for all related Systems ensuring all critical aspects are addressed and Final Report issued.
- Conduct Test Matrices for related Systems, ensure TMs 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.
- 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 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).
- 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 supports 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.
- Third level qualification in Science, Engineering or a relevant Quality discipline.
- 3 to 5 years similar experience in bio-pharma/life sciences manufacturing.
- DeltaV experience is an advantage.
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