Our client is a bio pharmaceutical company based in Waterford looking for a CSV Engineer to join the team to support on a Digital twin and packaging and serialisation projects.
- Provide coaching, oversight & decision making on complex CSV issues and associated support systems.
- Maintain validation philosophies, master plans and procedures required to drive the validation lifecycle of production recipes.
- Work in conjunction with Validation team, Production, Manufacturing Engineering and Quality Assurance to manage program and strategies aligned with site validation philosophies.
- Establish validation plans commensurate with the level of risk and manage the execution of validation projects whose scope, regulatory visibility, schedule requirements, and complexity require coordination with stakeholders.
Qualifications & Experience:
- BSc. in computer, engineering, mechanical, electrical engineering, chemical bio-engineering or relevant discipline is required.
- Minimum 5 years’ experience in Computer System Validation (CSV).
- In depth knowledge of the requirements for Computerised Systems and supporting system design.
- Working knowledge of cGMP type systems and practices is required.
- Strong foundation of Industrial Automation and Manufacturing IT Systems.
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
- Understanding of [21 CFR Part 11] Food and Drug Administration Code of Federal Regulations – Electronic Records, Electronic Signatures, Final Rule.
- Full interpretation of GAMP 5, EU GMP Annex 11 – EudraLex Volume 4 – EU guidelines to Good Manufacturing Practice – Products for Human and Veterinary Use, Annex 11: Computerised Systems.
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