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Senior CQV Engineer

Reference ID : NHA98
Category :
  • Pharma / Biotech
  • General Manufacturing
  • Science
  • Medical Devices
Date Posted : Dec 21, 2018
Job Location
  • Leinster
- Dublin
Experience : 5+ Yrs
Salary : Neg
Employment Type
Nicola O'Sullivan
Contact Number : 087 0622429
Experienced CQV Specialist required for Dublin based Biopharma multinational

Principal Responsibilities

Senior CQV Engineer

A Senior CQV Engineer is required to become a key member of the Engineering team within a leading Dublin based pharmaceutical multinational, this is an excellent career advancing opportunity with the successful candidate primarily leading all C&Q efforts relating to Utilities and Equipment.

Key Duties:

• Support Quality Risk Assessments for all related Systems. 
• Generate all Test Matrices for related Systems, ensure TM’s include all testing requirements and are approved and under revision control. 
• Review and approval of all Vendor Documentation 
• Lead for all Factory Acceptance Testing 
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. 
• Utilize and coordinate EDMQ System for review and approval of Protocols Lead for all execution work for related Systems - all Installation Verification deliverables = Walkdowns, Tag Verification, Loop Checks, Static Set to Work (STW), Pre-Start-up Safety Review (PSSR), Dynamic Set to Work (DSTW). 
• Generation of FV deliverables - Automation Checkout (ACO), Site Acceptance Test (SAT), Functional Testing, 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 

Qualifications & Requirements

Qualifications / Requirements:

• Prepare C&QSR’s (Commissioning Summary Reports) for executed documentation 
• Ensure all the requirements for the C&Q 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 C&Q deviations and exceptions. 

Candidate's Must have, previous experience commissioning and qualification experience, utilities and process equipment in the pharmaceutical industry. Candidates need to have at least 5 years in a similar role. 

HVACs Systems, chilled water and formulation vessel commissioning and qualification experience would make a candidate stand out. 
Candidates ideally need experience from a fill finish company

For more information contact Nicola on 087 0622429 or email your CV in the strictest confidence to jobs@headcount.ie

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