Process / Equipment Engineer

Pf Health

Ireland
**
Equipment technical support and troubleshooting
Root cause analysis and capa implementation
Cgmp re-validation and periodic review
** Pf Health is seeking a Process/Equipment Engineer to provide technical support for Bio-Vaccine Suites, focusing on equipment reliability, process improvements, validation, and compliance. The ideal candidate should have 5-8 years of experience in the biopharmaceutical industry, along with strong troubleshooting and communication skills. **

Job Summary

  • Provide process engineering/technical support to support the ongoing requirements of the Bio-Vaccines Suites, ensuring equipment is robust, reliable and all issues are resolved to support the effective and efficient manufacture and disposition of product.
  • Generate and implement documentation for cGMP re-validation and periodic review of systems, equipment and manufacturing processes including Annual Re-Validation Plans and Risk Assessments and IQ/OQ/PQ/QV Protocols and Reports.
  • Use Integrated Manufacturing Excellence (IMEx) and the Digital Operations Centre (DOC) to drive success in the Safety, Quality, Supply, Finance and People metrics and identify process & equipment improvements.

Matching Summary

Match Score: 75

** Pf Health is seeking a Process/Equipment Engineer to provide technical support for Bio-Vaccine Suites, focusing on equipment reliability, process improvements, validation, and compliance. The ideal candidate should have 5-8 years of experience in the biopharmaceutical industry, along with strong troubleshooting and communication skills. **

Skills & Requirements

Must-have

  • Equipment technical support and troubleshooting
  • Root cause analysis and CAPA implementation
  • cGMP re-validation and periodic review
  • Integrated Manufacturing Excellence (IMEx)
  • Digital Operations Centre (DOC)
  • Regulatory inspections experience

Nice-to-have

  • Patient centric company values
  • Breakthrough culture
  • Digital transformation strategy adoption
  • Diverse and inclusive workforce
  • Disability inclusion employer

Key Requirements

  • 5-8 years' industry experience
  • Biopharmaceutical/pharmaceutical experience preferred
  • Validation/revalidation systems experience
  • eQMS and QTS or similar compliance systems experience
  • MCS and PI working knowledge
  • Authorization to live and work in Ireland

Work Rights

Authorization to live and work in Ireland

Tailored Resume

Cover Letter