CSV Engineer – Digital Projects and Site Support (Hybrid)

  • Contract
  • Hybrid

Website Ref:TPM04426

Summary:
Our client is a biopharmaceutical company based in Waterford, looking or a CSV Engineer to join it’s team to drive digital projects and site support across multi disciplines.

Responsibilities:

  • 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 be hybrid but that is optional – if the candidate wants to be on site full time this is also an option.

Qualifications & Experience:

  • Degree in Computer, engineering, mechanical, electrical engineering, chemical bio-engineering or relevant discipline is required.
  • Working knowledge of cGMP type systems and practices is required.
  • 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.
  • Shows strong leadership skills and demonstrate the ability to work in cross-functional teams.

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