Are you a Senior CQV Safety Engineer with experience in the biotech or pharma industries? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior CQV Safety Engineer - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
Lead Set to Work and CQV Safety deliverables for Project through Design, Construction and CQV testing Phases.
- Lead generation, review and approval of all Set to Work documents and associated Drawings
- Lead generation, review and approval of all PSSR (Pre-Start-up Safety Review) documents and associated Drawings
- Project Safety Lead for all Start-up, STW, PSSR, Walkdowns and IV and FV field executions
- Liaise with all CQV Work-stream Lead Engineers in relation to STW, PSSR, Walkdown and IV/FV
- Lead and Coordinate all STW and PSSR meetings, ensure all associated documentation is sent for draft, review and approval within CQV Tracker timelines
- Review of P&ID?s in relation to Commissioning System Boundaries, Start-up of Systems and Set to Work
- Safety assistance with all Quality Risk Assessments (QRAES) for all Systems
- Start-up review of Assist with all System Classification Boundary Diagrams (SCBD)
- Safety and Start-up representative for all Work-stream Design Reviews
- Safety and Start-up input into the writing and execution effort for all Verification Documentation (FAT/RV/SAT/IV/SAT/FV)
- Review and approval of all contractor and Fluor / Sisk Method Statements
- Ensure GEP and GDP requirements for ?leverage-able? test documentation are adhered to
- Ensure valued input into Start-up CQV Schedule and Milestones
- Assist with coordination of all IV deliverables (Walkdowns, Tag Verification, Loop Checks, Static Set to Work (STW), Pre-Start-up Safety Review (PSSR), Dynamic Set to Work DSTW)
- CQV Safety review of and Engineering Change Management (ECM) raised
- Prioritise Start-up Document preparation activities in line with the project schedules and business needs
- Support CQV and QA programmes as required
- Ensure valued input into HAZOP sessions and where applicable sign off of HAZOP actions
- Start-up and Safety input into all Test Matrices for related Systems, ensure TM?s include all Start-up 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 STW Lead will be measured against.
- Safety review of all Vendor Data Requirement deliverables
- Safety review of all Factory Acceptance Testing
- Liaise with Document Preparation Lead in relation to producing Protocols (FAT/IV/SAT/FV).
- Liaise with RV Lead to ensure all RV deliverables are executed as per Project Procedures and items are installed in a safe, controlled and compliant manner
- Review Fluor/Sisks Just in Time Schedule to ensure all deliveries of Equipment are inspected and installed in a safe, controlled and compliant manner
- Review and approve all Contractor and Vendors Method Statements and Work Instructions
- Oversight into all Fluor/Sisk Permits and LOTO System prior to Mechanical Completion
- Lead CQV Engineer responsible for driving and implementing Permit and LOTO System post Mechanical Completion, ensure that all Safety Procedures and Standards are adhered to
- Attend Daily and Weekly CQV Meetings
- Safety and Start-up Lead for all IC and FW Walkdowns
- Review of all Safety related punch items for all Systems
- Safety CQV Lead for all FV deliverables = Start-up, De-bugging, Automation Checkout (ACO), Site Acceptance Test (SAT), Phase and Recipe Testing
- CQV Lead point person for all Project v Site Safety issues or concerns
- Review of all PED Certification for all systems
Requirements:
Educated to degree level or equivalent.
Significant experience within a Pharma - Biotech sector
Package:
Contract rate of 50 - 60 euro per hour
Minimum Contract duration: 6 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
Are you a Senior CQV Safety Engineer with experience in the biotech or pharma industries? Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.
Senior CQV Safety Engineer - Amgen - Dublin
Employer
Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
Job Description
Lead Set to Work and CQV Safety deliverables for Project through Design, Construction and CQV testing Phases.
- Lead generation, review and approval of all Set to Work documents and associated Drawings
- Lead generation, review and approval of all PSSR (Pre-Start-up Safety Review) documents and associated Drawings
- Project Safety Lead for all Start-up, STW, PSSR, Walkdowns and IV and FV field executions
- Liaise with all CQV Work-stream Lead Engineers in relation to STW, PSSR, Walkdown and IV/FV
- Lead and Coordinate all STW and PSSR meetings, ensure all associated documentation is sent for draft, review and approval within CQV Tracker timelines
- Review of P&ID?s in relation to Commissioning System Boundaries, Start-up of Systems and Set to Work
- Safety assistance with all Quality Risk Assessments (QRAES) for all Systems
- Start-up review of Assist with all System Classification Boundary Diagrams (SCBD)
- Safety and Start-up representative for all Work-stream Design Reviews
- Safety and Start-up input into the writing and execution effort for all Verification Documentation (FAT/RV/SAT/IV/SAT/FV)
- Review and approval of all contractor and Fluor / Sisk Method Statements
- Ensure GEP and GDP requirements for ?leverage-able? test documentation are adhered to
- Ensure valued input into Start-up CQV Schedule and Milestones
- Assist with coordination of all IV deliverables (Walkdowns, Tag Verification, Loop Checks, Static Set to Work (STW), Pre-Start-up Safety Review (PSSR), Dynamic Set to Work DSTW)
- CQV Safety review of and Engineering Change Management (ECM) raised
- Prioritise Start-up Document preparation activities in line with the project schedules and business needs
- Support CQV and QA programmes as required
- Ensure valued input into HAZOP sessions and where applicable sign off of HAZOP actions
- Start-up and Safety input into all Test Matrices for related Systems, ensure TM?s include all Start-up 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 STW Lead will be measured against.
- Safety review of all Vendor Data Requirement deliverables
- Safety review of all Factory Acceptance Testing
- Liaise with Document Preparation Lead in relation to producing Protocols (FAT/IV/SAT/FV).
- Liaise with RV Lead to ensure all RV deliverables are executed as per Project Procedures and items are installed in a safe, controlled and compliant manner
- Review Fluor/Sisks Just in Time Schedule to ensure all deliveries of Equipment are inspected and installed in a safe, controlled and compliant manner
- Review and approve all Contractor and Vendors Method Statements and Work Instructions
- Oversight into all Fluor/Sisk Permits and LOTO System prior to Mechanical Completion
- Lead CQV Engineer responsible for driving and implementing Permit and LOTO System post Mechanical Completion, ensure that all Safety Procedures and Standards are adhered to
- Attend Daily and Weekly CQV Meetings
- Safety and Start-up Lead for all IC and FW Walkdowns
- Review of all Safety related punch items for all Systems
- Safety CQV Lead for all FV deliverables = Start-up, De-bugging, Automation Checkout (ACO), Site Acceptance Test (SAT), Phase and Recipe Testing
- CQV Lead point person for all Project v Site Safety issues or concerns
- Review of all PED Certification for all systems
Requirements:
Educated to degree level or equivalent.
Significant experience within a Pharma - Biotech sector
Package:
Contract rate of 50 - 60 euro per hour
Minimum Contract duration: 6 months
Contact:
Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720
Click to connect with Karen on LinkedIn
Similar Jobs
Amgen Jobs in Ireland
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
