CSV Engineer

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I am working with one of the world's Leading Biotechnology companies. They are currently building Ireland's largest bulk biologics production facility. The facility is based in Limerick and the company. They have a strong culture of R&D and Innovation and offer successful candidates huge progression and development opportunities.

They are currently recruiting for a CSV Engineer. The individual in this position implements policies and procedures to validate/qualify production automation/enterprise systems. Plans, coordinates, and participates in a compliant validation process for production automation/enterprise systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

Duties and Responsibilities:

* Investigates and troubleshoots problems with Rockwell Automation and Siemens automation control systems which occur and determines solutions or recommendations for changes and/or improvements.

* Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.

* Ensure compliance with automation system coding standards such as S88 and ISA 95.

* Lead process improvement projects to improve the validation of computerized systems Coordinates with other departments or outside contractors/vendors to complete validation tasks. Participates in regulatory audits and communicates company's computer validation policies.

* Assesses company's computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure best data integrity practices are enforced.

* Trains /advises less experienced Specialists and Technicians. Possesses a thorough understanding and experience of Validation Principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211.

* Technical writing experience. Generation, Review and Approval of Validation documents. .

Education and Experience:

Requires BS/BA in Engineering, Chemistry, or Life Sciences with 5+ years of related experience within the fields of automation, enterprise systems and biotechnology; will substitute relevant experience for education.

This is an opportunity to join their select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about the companies unwavering commitment to combining good science & good business.

For immediate consideration please reply with an up to date CV. Not sure yet? No CV ready? Give me a call for more information

Sthree UK is acting as an Employment Agency in relation to this vacancy.