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CSV Engineer - Digital Twin and Packaging/ Serialisation

Manpower Ireland
Closing date
16 Feb 2023

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Job Type

* 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. You are trained as a GMP auditor to support internal GxP audits of computerised systems.
* Lead qualification of (MES) Manufacturing Execution System and associated outbound and inbound system
* 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


The role will require:
* Project support - Digital Twin
* Packing and Site Serialisation support
* Site support

* BS in Computer, engineering, mechanical, electrical engineering, chemical bio-engineering or relevant discipline is required
* Minimum of 5 + years of experience with MES (Manufacturing Execution Systems) (Werum Pas-x) pharmaceutical process systems executing design, commissioning, troubleshooting activities is required
* Working knowledge of cGMP type systems and practices is required
* Strong foundation of Industrial Automation and Manufacturing IT Systems
* Computer System Validation (CSV) Experience 5+

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