CSV Engineer

Website Ref: TPM04468

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.

To apply for this job email your details to orla.daly@tandempm.ie.