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
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 applications@lifescience.ie
Details

Computer Systems Validation Engineer


Reference:AKJC-586750 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Computer Systems Validation Engineer
Our Dublin based client are currently recruiting for a Computer Systems Validation Engineer to join their team on a permanent basis. As Computer Systems Validation Engineer, you will report directly into the Technical Services Manager.

Responsibilities
• Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) projects
• Support and co-ordinate the qualification and validation processes
• Support the preparation of Validation/Qualification Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ, OQ/PQ), Data Migration, SOPs and Change controls
• Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures
• Support the resolution of project deviations/errors and provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
• Responsible for ensuring that the Technical Services Manager is consulted on all validation deliverables
• Conduct validation training with project team communicating deliverables, procedures and methods

Requirements
• A minimum of a Bachelor’s degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech)
• Validation experience with ERP, MES, LIMS, and Quality Systems is preferred
• Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required
• Strong knowledge of computerized system development life cycle approach is required
• The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required
• Strong leadership skills and the ability to work in cross-functional team environments, as well as independently
• Excellent PC skills with proficiency in automation systems
• Experience of coordination of Quality documentation and in particular, qualification/Validation documentation
• Strong written and verbal communication skills are required

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252