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Validation Engineer

Job Seekers Ireland Health Pharmaceutical

Job Summary

  • Waterford
  • Permanent
  • 1779
  • Jul 05, 2022
  • Competitive
Job Description

The purpose of this position is to be the subject matter expert in our Fill Finish validation operation and be a recognised expert in this industry.

Qualifications and Skills Required

  • Bachelor's degree (or equivalent) in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical)

  • Further qualifications (e.g. Masters) preferred.

  • At least 12+ years relevant experience in a pharmaceutical manufacturing environment, with at least 6+ years' experience in a comparable Validation Engineering role.

  • Must have experience working in a sterile manufacturing environment.

  • Requires prior experience performing validations of multiple systems and equipment in a time-sensitive start-up program.

  • Knowledge of requirements for design, installation, commissioning, qualification and validation of pharmaceutical equipment, systems and utilities using risk-based approaches.

  • Knowledge of leveraging test data from early stage project testing into later stages (e.g. FAT into SAT/IOQ).

  • Knowledge of regulatory validation requirements including FDA, EMA and all other applicable worldwide Regulatory requirements (ICH Q7, Q8, Q9).