A CSV Engineer is required by CareerWise Recruitment for our Waterford based pharmaceutical client. This is a 12-month contract this can be a hybrid position.
Role of this position
- 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.
- 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
- 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+
Please call Louise Mulligan today for further information on 0949003979 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)