Website Ref: TPM04468
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.
- 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.
To apply for this job email your details to email@example.com.