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 companys computer validation policies.
*Supports the Quality Approval of Vendors and Suppliers of GxP computer systems *Assesses companys 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 for a friendly chat today.
Skills:
CSV Compliance protocols