Connecting...

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

Responsibilities:

  • 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

 Experience:

  • 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:   chloe.walsh@sigmar.ie  

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

 

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.