Are you a Senior CQV Engineer with Clean Utilities 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 Engineer - Clean Utilitiies - 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
Primarily lead all CQV efforts relating to Clean Utilities. ?
Lead and coordinate all QRAES (Quality Risk Assessments) for all related Systems ensuring all critical aspects are addressed and Final Report issued. ?
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 ?
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
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:
Educated to degree level or equivalent.
Significant experience within a Pharma - Biotech sector
Package:
Contract rate of 55 - 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 Engineer with Clean Utilities 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 Engineer - Clean Utilitiies - 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
Primarily lead all CQV efforts relating to Clean Utilities. ?
Lead and coordinate all QRAES (Quality Risk Assessments) for all related Systems ensuring all critical aspects are addressed and Final Report issued. ?
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 ?
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
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:
Educated to degree level or equivalent.
Significant experience within a Pharma - Biotech sector
Package:
Contract rate of 55 - 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