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
Contact Info
Sean McCarthy
Life Science

+3530212339371
[email protected]
Connect with me on
Trainer
Dublin
Senior Quality Engineer-Remote
Republic of Ireland
R&D Director
Galway
Responsible Person (RP)
Republic of Ireland
R&D Director
Galway
Project Engineer
Limerick
Senior Recruitment Consultant
Republic of Ireland
Medical Device Director
Republic of Ireland
R&D Manager
Galway
R&D Manager
Galway
R&D Engineer
Dublin
R&D Manager
Galway
Process Engineer
Limerick
R&D Manager
Galway
Head of R&D
Galway
C&Q Lead
Tipperary
Qualified Person
Limerick
Recruitment Consultant
Republic of Ireland
Chemical Engineer
Tipperary
Project Engineer
Republic of Ireland
Quality Specialist
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Project Engineer
Tipperary
QC Analyst
Meath
CQV Lead
Tipperary
Graduate Laboratory Technician
Republic of Ireland
Project Manager
Limerick
Senior Manufacting Engineer
Republic of Ireland
R&D Director
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

Commissioning, Qualification and Validation Engineer


Reference:SMC72956 Location: Carlow
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: Process Engineer

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.



Duties

  • As such you will be executing with a view to leveraging testing from Commissioning and Qualification to PQ where possible.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • Implementing the requirements as outlined in the site / C&Q and project Validation Master Plan.
  • Coordination of engineering sub-teams in the assigned suite during execution of IQ/OQ / Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including IOC/ IOQ & PQ protocols.
  • Technical owner of Commissioning protocols, Qualification protocols and input to Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
  • Input to Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
  • Effective application of LeanSixSigma and Change Management tools in the Validation group by:
  • Leading by example in achieving results by using industry standard tools and processes
  • Facilitate problem solving & risk assessment (FMEA) projects/meeting.
  • Make problems visible and strive for continuous improvement.
  • Serving as a key member during internal audits and external inspections/audits.
  • Support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc).
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

Education & Experience

  • Minimum 3 years process equipment C&Q/ Validation experience on Large Scale Projects
  • SME on Equipment Validation on any of; Parts Washer / Autoclaves / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities - Transfer Panels & Formulation / Visual Inspection/ Single Use Technologies

If interested in this posting please feel free to contact Seán McCarthy on +353 (0)87 798 8480 or [email protected] for further information.