2022-802-CSV Engineer-Waterford Contractor

This is a 12-month initial contract.

Purpose:

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.

Responsibilities:

• Maintain validation philosophies, master plans, and procedures required to drive the validation lifecycle of production recipes
• Work in conjunction with the Validation team, Production, Manufacturing Engineering, and Quality Assurance to manage programs 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
• BS in Computer, engineering, mechanical, electrical engineering, chemical bio-engineering, or relevant discipline is required
• Working knowledge of cGMP-type systems and practices is required
• A strong foundation of Industrial Automation and Manufacturing IT Systems