CSV Engineer

Summary:
Our client is a biopharmaceutical company based in Waterford looking for a CSV Engineer to join their team. The successful candidate will be responsible for maintaining validation philosophies, master plans and procedures required to drive the validation lifecycle of production recipes.

Responsibilities:

• In depth knowledge of the requirements for Computerised Systems and supporting system design.
• 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.
• [21 CFR Part 11] Food and Drug Administration Code of Federal Regulations – Electronic Records, Electronic Signatures, Final Rule.
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
• Competent at coaching, oversight & decision making on complex CSV issues and associated support systems. You show strong leadership skills and demonstrate the ability to work in cross-functional teams.
• 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.
• Project support.
• Digital project support.
• Site support.

  Qualifications & Experience:

• BS in Computer, engineering, mechanical, electrical engineering, chemical bio-engineering or relevant discipline is required.
• Computer System Validation (CSV) Experience 5+.
• Working knowledge of cGMP type systems and practices is required.
• Strong foundation of Industrial Automation and Manufacturing IT Systems.