Senior Csv Engineer

AstraZeneca

Dublin, Ireland
**
Computer system validation (csv)
Gxp-relevant automation and digital systems
Eu gmp annex 11, 21 cfr part 11, gamp 5
** AstraZeneca is seeking a Senior CSV Engineer for its new API manufacturing facility in Dublin. The role involves leading Computer System Validation (CSV) efforts for GxP-relevant automation and digital systems, ensuring regulatory compliance and operational efficiency within a cutting-edge manufacturing environment. **

Job Summary

  • Join AstraZeneca at a pivotal moment as we build a next-generation API manufacturing facility developed to accelerate commercial product launches and set new standards for digital, sustainable manufacturing.
  • You will provide technical leadership across Computer System Validation (CSV), ensuring that all GxP-relevant automation, IT/OT, and digital systems are developed, implemented, and operated in line with regulatory expectations and industry standard process.
  • We develop a culture where ideas are welcomed, teamwork is encouraged, and people are empowered to make an impact.

Matching Summary

Match Score: 75

** AstraZeneca is seeking a Senior CSV Engineer for its new API manufacturing facility in Dublin. The role involves leading Computer System Validation (CSV) efforts for GxP-relevant automation and digital systems, ensuring regulatory compliance and operational efficiency within a cutting-edge manufacturing environment. **

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • GxP-relevant automation and digital systems
  • EU GMP Annex 11, 21 CFR Part 11, GAMP 5
  • Risk-based validation strategies
  • IT/OT architecture support
  • Data integrity and access control

Nice-to-have

  • Continuous improvement in validation
  • Digital manufacturing environments
  • Inspection readiness support
  • Teamwork and empowerment culture

Key Requirements

  • Significant experience delivering CSV
  • Experience supporting capital projects and facility start-ups
  • Degree or equivalent experience in Engineering, Computer Science, Automation, or related technical field

Work Rights

Not specified

Tailored Resume

Cover Letter