Computer System Validation Engineer

Ireland West – Sligo

Permanent

Did you ever wish you joined a company at the start, when things where going from start up to ramp up? This is the prefect role for you to consider if you are looking to make a real impact and for you to be proud of being part of this great place to works company journey.

I am looking to speak with options that have circa 3 years experience in CSV and the following would be highly desirable;

·      Managing CSV automation change controls and non conformances.

·      Be part of a review of CSV procedures and protocols

·      Ensure compliance for CSV

·      Annex 11

·      Experience with ERP in a GMP manufacturing environment.

Day to Day :

·      Prepares/reviews validation documentation related to projects/change controls including risk assessments, traceability matrices, and validation reports

·      Executes validation activities and protocols on affected systems

·      Manages computer system /automation related change controls and other compliance related tasks e.g. non-conformances.

·      Participates in the creation and review of existing and new CSV procedures and polices.

·      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.

·      Auditing of internal projects against internal validation policies and procedures

·      Managing and co-ordinating the review and approval of specifications associated with Computerised Systems

·      Coordinates with internal Global Departments or outside contractors/vendors to complete validation tasks.

·      Reviewing and approving vendor validation documentation

·      Participates in regulatory audits and communicates company’s computer validation policies.

·      Supports the Quality Approval of Vendors and Suppliers of GxP computer systems

·      Assesses company’s computer systems and identifies / addresses any potential 21CFR Part 11 or EU Annex 11 gaps.

·      Manages projects and prepares status reports using Microsoft project and other communication tools.

·      Supports local IT and Global IT on maintenance and testing of physical network infrastructure and security

Qualifications, Experience and Skills:

·      Requires third level degree in Science, Engineering or Computer Science with 3+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.

Reach out to [email protected] for a friendly chat today.