I'm looking for...

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.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Paula O'Reilly
Life Science

+353 1 507 9265
[email protected]
Connect with me on
VP of R&D
Process Engineer
GMP Inspector
Risk Manager
Quality Engineer
Principal R&D Engineer
Dublin Greater
Clinical Project Manager
Republic of Ireland
R&D Manager
Apply for this job






Salary Expectations:



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]

QA Validation CSV Specialist / Snr Specialist

Reference:POR807431 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Validation Specialist

A QA Validation CSV Specialist or Senior Specialist is required to join a rapidly expanding global Biopharmaceutical business in Limerick. The main focus of this role is to implement policies and procedures to validate/qualify computer systems. You will plans, coordinate, and participate in a compliant validation process for quality information technology systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

The Role

  • Analyses the results of testing and determines the acceptability of results against predetermined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
  • Lead process improvement projects to improve the validation of computerized systems
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Participates in regulatory audits and communicates company’s computer validation policies.
  • Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.
  • Trains /advises less experienced Specialists and Technicians.
  • Advise and support all teams on computer validation activities.

The Person

  • Requires BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the fields of computers and biotechnology.
  • Experience with process control systems necessary.
  • Possess a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.
  • Technical writing experience.
  • Experienced in the Generation of Validation documents.
  • Experience of the review and approval of Validation documents.
  • Strong attention to detail and accuracy.
  • Experience in risk assessments in relation to validation activities.

For further details please contact; Paula O’Reilly on 087 7094141 or send CV in confidence to [email protected]