Sterilisation Validation

Job description

Sterilisation Validation/ Biocompatibility Engineer 1

Associate Quality Engineer

Our Quality Engineers are directly involved in building the organization in support of Sterility Assurance & Biocompatibility assessments for New Product Development and Site Transfers


  • Support sterility assurance & biocompatibility activities for new products and change control, developing strong partnering relationships with these groups, at both manufacturing and design sites
  • Participate in root cause investigations and continuous improvement in day-to-day activity, initiating appropriate corrective actions and following through to implementation
  • Support your projects in internal and external audits and in submission preparation, addressing any questions regarding these submissions
  • Perform calculations, technical and record keeping duties in conformance with company and regulatory policies and standards to meet quality and accuracy requirements
  • Review systems and processes for optimization and troubleshooting
  • Adhere to all relevant site wide procedures and practices for Safety & GMP


  • Degree (Level 8) qualification in relevant technical discipline e.g Science or Engineering
  • 2-3 years’ experience with Sterilisation Validation or Biocompatibility is desirable
  • Excellent understanding of GMP and documentation required
  • Dynamic team player with good communication skills
  • Can work effectively and proactively as an individual or on cross functional teams


To apply for this position please contact Chloe Walsh at Sigmar Recruitment T: +353 91 455305 E:  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent


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