Job ID: JOB-11608
We are now recruiting a Contingent/Contractor CSV Engineer, to join our diverse Validation team in Mayo. As our CSV Engineer you will support upgrading custom applications by authoring change controls, risk assessments, integration protocols, test scripts and summary reports and by updating SOPS, training material and equipment asset care activities as required.
So, what do you need to do this role?
- The Validation engineer will provide guidance to the project team on up-to-date and relevant regulatory requirements and will work closely with other members of the project team and business process owners to ensure upgrades are executed and delivered in a timely manner.
- The Validation Engineer will develop and promote good practices to continuously improve the quality and effectiveness of the IT processes, achieving the appropriate level of regulatory compliance, and act in close partnership with all stakeholders to ensure consistency in quality approach, including:
o Third Parties Quality Management
o Internal Control and Risk Management
o Predictive Compliance Planning and Remediation
o Weekly and Monthly dashboards
o Support updating of SOP’s
o Review & Approvals of SDLC documentation in line with SDLC requirements
o Ensure inspection readiness of the project.
- A degree in Engineering, Computer Science, or related discipline / equivalent experience.
Technical Skills and Experience
- A minimum of– 4 years’ experience working in Computer System Validations in Pharmaceutical and/or Medical device industry.
- A Strong background in software development and test with in-depth understanding of relevant GAMP and relevant EU/FDA regulations around software and data systems.
- Extensive experience with GxP and GDP practices, 21 CFR Part 11 and good working knowledge of Data Integrity
- Proven ability to work without direct supervision within a complex project team.
- Strong verbal and written communication skills.
- Experience with delivering complex projects, ideally related to legacy manufacturing modernisation / manufacturing system upgrades to support business critical process equipment.
- CSV experience in at least one of the following areas: Laboratories, Aseptic Processing or packaging equipment.
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