I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome		 IE
Internet Explorer		 firefox
Mozilla Firefox		 opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Job Tools
Contact Info
Angela McCauley
Life Science

+353 87 696 0951
[email protected]
Connect with me on
Hot Science Jobs
C&Q Lead
Tipperary
Recruitment Consultant
Republic of Ireland
Senior Design Engineer
Dublin
R&D Program Manager
Dublin
R&D Manager
Galway
Technical Transfer Specialist
Cork
Master Data Associate
Limerick
R&D Engineer
Galway
Packaging Engineer
Dublin
R&D Engineer
Dublin
QA Manager
Canada
Director of Quality Engineering
Limerick
Senior Equipment Design Engineer
Dublin
Senior Equipment Design Engineer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
Product Development Engineer
Galway
Maintenance Engineer
Carlow
Senior Project Engineer
Cork
Senior R&D Engineer-New Product Deve
Westmeath
Quality Engineer
Wexford
Senior Regulatory Affairs Specialist
Westmeath
Project Engineer
Roscommon
Maintenance Planner
Westmeath
Recruitment Consultant
Wexford
Lead Maintenance Reliability Engineer
Westmeath
Project Engineer - Senior
Cavan
Advanced Technologies Manager
Galway
QA Engineer
Leitrim
Senior Regulatory Affairs Specialist
Athlone
R&D Engineer
Dublin
Senior HVAC Engineer
Dublin
Quality Systems Manager
Dublin
Senior Design Assurance Engineer
Galway
Principal Engineer
Dublin
Quality Engineer
Galway
Project Manager
Limerick
Senior Quality Engineer
Dublin
Commissioning and Qualification Engineer
Cork
Validation Engineer
Cork
Senior Equipment Design Engineer
Dublin
Project Manager - Suite Lead
Tipperary
NPI Process Engineer
Carlow
Senior Validation Engineer
Dublin
R&D Manager
Connaught
R&D Engineer
Clare
Senior Product Development Engineer
Galway
Head of R&D
Galway
Associate Director Clinical Regulatory S
Cork
Process Chemist
Limerick
Senior Operations Engineer
Galway
Project Manager - Capital Projects
Meath
R&D Engineer
Galway
Manager R&D
Connaught
Project Manager - Capital Projects
Cork
R&D Director
Galway
R&D Senior Program Manager
Galway
Production Operator
Dublin
Product Development Engineer
Galway
Process Development Engineer
Galway
Senior Equipment Engineer
Dublin
Senior Recruitment Consultant
Dublin
Senior Design Engineer
Dublin
Senior Project Manager - Process Develop
Dublin
Microbiology Manager
Dublin
Quality Systems Specialist
Galway
R&D Director
Galway
Product Development Engineer II
Athlone
Senior Process Engineer
Cork
Senior Electronic Design Engineer
Dublin
Quality Specialist
Tipperary
Senior Maintenance Technician
Roscommon
Senior Equipment Design Engineer
Dublin
Technical Life Cycle & Engineering M
Galway
Clinical Trial Quality Representative
Cork
R&D Manager
Connaught
Electronic Design Engineer
Galway
Account Manager UK and Ireland
Republic of Ireland
Shift Technician (Injection Moulding)
Kildare
Senior Reg Affairs Specialist - Post Mar
Galway
Biostatistician
Dublin City Centre
Quality Engineer
Athlone
Principal Quality Engineer
Galway
Scientist - Process Cleaning
Limerick
Product Development Engineer
Dublin
Technical Specialist - Analytical &
Cork
Senior Operations Engineer
Galway
R&D Engineer
Galway
Quality Systems Specialist
Cork
Change Control Lead
Tipperary
Process Engineer
Cork
R&D Engineer
Galway
Injection Moulding Engineer
Leitrim
Senior Recruitment Consultant
Dublin
Quality Systems Specialist
Cork
QC Laboratory Technician
Carlow
R&D Lifecycle Manager
Connaught
R&D Engineer
Clare
Principal/Senior R&D Engineer Cathet
Galway
Senior Engineering Manager
Limerick
Quality Technician
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Senior R&D Engineer
Clare
Senior Project Engineer - Utilities
Dublin
QA Supplier Specialist
Carlow
R&D Engineer
Galway
Manufacturing Project Engineer
Sligo
R&D Engineer
Galway
Chief Medical Officer
Dublin
Senoior Specialist - MS&T
Dublin
Specialist Operations Engineer
Tipperary
Injection Moulding Engineer
Athlone
QC Bioassay Analyst
Carlow
Senior Technical Transfer Engineer
Cork
R&D Manager
Galway
Senior Research and Development Engineer
Galway
Aseptic Process Lead
Carlow
Compliance Specialist
Carlow
Senior Manufacturing Engineer
Cork
Production Operator
Carlow
Clean Utilities Engineer
Cork
Senior Process Engineer
Cork
Principal R&D Engineer
Dublin
Senior Project Equipment Engineer
Dublin
Principal R&D Engineer
Galway
Senior R&D Engineer
Galway
QC Associate Microbiology Specialist
Carlow
Production Operator
Carlow
Quality Engineer
Galway
Principal R&D Engineer
Dublin
Senior Recruitment Consultant
Republic of Ireland
Software Design Assurance Engineer
Dublin
E&I Turnover Engineer
Carlow
Senior Human Factors Engineer
Dublin
Chemical Engineer
Tipperary
Process Support Specialist
Carlow
Senior Quality Engineer
Leitrim
Validation Engineer
Athlone
Senior Quality Engineer
Leitrim
Clean Utilities Engineer
Carlow
Manufacturing Engineer
Cork
Senior Mechanical Engineer
Dublin
Senior R&D Engineer
Galway
Principal Software Engineer
Athlone
R&D Director
Galway
Quality Assurance Operations (Hybrid)
Meath
Senior Quality Assurance Specialist
Dublin
Quality Specialist & Deputy RP
Limerick
Project Manager - R&D
Galway
Technology Transfer Specialist (Technica
Cork
Principal R&D Engineer
Galway
Staff R&D Engineer- Customer Focus
Dublin
Injection Moulding Engineer
Athlone
Quality Engineer
Athlone
Senior Associate Quality Control NPI
Dublin
Project Engineer
Tipperary
Senior Project Engineer
Cavan
Production Operator
Carlow
Material Handler
Carlow
Maintenance Reliability Engineer
Tipperary
Responsible Person (RP)
Republic of Ireland
Senior R&D Manager - Lifecycle Manag
Galway
Senior Electronics Engineer
Dublin
Project Engineer
Limerick
Manufacturing Biotech Associate 24/7 Shi
Meath
Senior Manufacting Engineer
Republic of Ireland
Change Control Coordinator
Carlow
Notified Body Product Assessor -Active D
Canada
Quality Manager
Dublin
R&D Manager
Galway
Senior R&D Engineer
Dublin
Product Lead
Dublin
Operations Lead
Dublin
Manufacturing Engineer
Galway
Upstream Manufacturing Process Specialis
Cork
Senior Quality Engineer
Dublin
Project Engineer
Cork
Senior Process Development Engineer
Galway
Senior Quality Control Associate
Dublin South
Cleaning Validation Specialist
Carlow
Cleaning Validation Specialist
Cork
Senior R&D Engineer
Dublin
Senior R&D Manager - Lifecycle Manag
Galway
Technical Specialist - Manufacturing Pro
Cork
Maintenance CMMS Engineer
Tipperary
QA Manager
Canada
Senior Recruitment Consultant
Republic of Ireland
Quality Technician
Dublin
Sales/Customer Service Administrator
Clonmel
Manufacturing Technician
Clare
R&D Manager
Athlone
Principal Process Development Engineer
Galway
Senior R&D Manager
Athlone
Senior Validation Engineer
Limerick
R&D Manager
Connaught
Senior R&D Engineer
Dublin
Product Development Technician II
Galway
Injection Molding Engineer
North Leinster
Commisioning and Qualification Engineer
Cork
Technical Transfer Specialist - Remote
Republic of Ireland
Manufacturing Project Engineer
Mayo
Project Engineer
Republic of Ireland
Senior Regulatory Affairs Specialist
Athlone
Senior R&D Engineer
Dublin
Quality Assurance Engineer
Longford
Facilities Engineer
Carlow
Senior Regulatory Affairs Specialist
Athlone
R&D Manager
Connaught
R&D Project Manager
Galway
Senior Regulatory Affairs Specialist
Athlone
Senior Regulatory Affairs
Galway
Clean Utilities Engineer
Carlow
Validation & Verification Engineer
Dublin
Project Enginer
Dublin South
Business Systems Director
Louth
Manufacturing Technician
Clare
Validation Engineer
Carlow
Scientist (hybrid)
Meath
Senior R&D Manager - Lifecycle Manag
Galway
Quality Specialist - Remediation
Louth
CQV Lead
Tipperary
Product Development Engineer
Galway
Reliability Engineering Specialist
Louth
Pharmacovigilance Manager (Remote)
Republic of Ireland
Process Engineer
Limerick
Supply Chain Import / Export Specialist
Dublin
Process Microbiologist
Cork
Suite Team Delivery Lead
Tipperary
Principal Heart Valves Engineer
Galway
Biomedical Engineer
Dublin
Cleaning Validation Specialist
Cork
R&D Manager
Galway
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Commisioning and Qualification Engineer


Reference:AM0058 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Project Engineer

Biotech - Cork
C&Q Engineer
12 month contract
On site - Cork

As part of the Technical Compliance Team, this contract position is responsible for all activities required to support project commissioning and qualification.

The role of the C&Q Engineer and associated activities include, the preparation and execution of commissioning and qualification protocols for site systems / equipment such as Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / grey utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).

The ideal candidate would have 5+ years experience in API industry including several years working in Commissioning and Qualification of equipment

Job Responsibilities:

  • Provide input into all aspects of C&Q i.e. from design through to commissioning and qualification completion.
  • Support and participate in the design of systems and equipment to ensure they comply with cGMP requirements.
  • Prepare C&Q protocols as required (e.g. URS?s / SRS?s, Plans, Impact Assessments, DQ, IQ, OQ, PQ protocols and Reports).
  • Review and approve documents prepared by contractor organisations (e.g. vendor SATs, FATs, commissioning protocols, project change controls/notifications).
  • Execute C&Q protocols as required.
  • Compile relevant documentation from vendors, contractors, and other departments for inclusion in protocols / reports.
  • Complete activities / deliverables in accordance with each projects site change control required deliverables (from a C&Q perspective).
  • Track and support the resolution of Commissioning punch list items and Qualification deviations during the C&Q execution phase.
  • Prioritize C&Q activities in line with site and project schedules.
  • Co-ordinate C&Q activities with project engineering, construction and site operations activities.
  • Co-ordinate C&Q activities with contractors and vendors as required.
  • Co-ordinate C&Q document reviews and approvals.
  • C&Q System / Equipment / Components as per site procedures.
  • Strong collaboration with Quality Department.

Experience
  • Minimum 5+ years experience in the Pharmaceutical (API) Industry.
  • Experience of commissioning and qualifying some of the following systems:
    • Reactors, Centrifuges, Dryers, Powder Handling Units, Skids, Vessels, Tanks, Pumps, Laminar Airflow Booths, autoclaves and isolators and clean / grey utility systems (such as purified water, water for injection clean steam, HVAC, Process Gases, Steam and Condensate systems etc.).
  • Experience preparing and executing commissioning and qualification protocols and reports.
  • Knowledge and experience of Project Delivery Processes (PDP).
  • Knowledge and experience of current Good Engineering Practices (GEP).

Following would be an advantage,
  • Experience with use of ABB Industrial IT control systems.
  • Experience of Pharmaceutical facility local and controlling instrumentation
  • Extensive experience of commissioning and qualification of production systems, utilities and facilities and change management.
  • Experience of working within a Technical Compliance / Project team in a multinational corporate environment
  • Experience of ASTM 2500 and/or Risk Based Qualification approach.
Apply today or get in touch with Angela McCauley at Life Science recruitment for more info on this and similar roles.