Job Details: Senior CQV Engineer


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Senior CQV Engineer


Are you a Senior CQV Engineer with experience Packaging 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 Packaging 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

Primarily lead all CQV efforts relating to Packaging. ?

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 experience Packaging 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 Packaging 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

Primarily lead all CQV efforts relating to Packaging. ?

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

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