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Computer Systems Validation Engineer

Location: Dublin
Experience:3-4 Years
Job Type:Permanent
Salary:Not Disclosed
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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.

• 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

• 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


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