About your company We are seeking a motivated and detail-oriented Sterilization Validation Engineer I to join a leading medical device company in Galway.
This is a 12-month contract position.
You will play a key part in supporting critical sterility assurance activities and ensuring the highest standards of quality and compliance across our manufacturing and product development processes.
Your responsibilities as a Sterilization Validation Engineer I Support sterility assurance activities including GMP compliance, cleanroom risk assessments, dose audits, cycle requalification, and supplier change control.Collaborate with manufacturing and design teams on sterility strategies for new products and change controls.Contribute to root cause investigations and implement corrective actions to drive continuous improvement.Assist cross-functional teams in designing test protocols to ensure compliance with regulatory standards.Work closely with engineering and manufacturing to uphold quality standards across processes.Develop and apply inspection and testing methods to ensure product and equipment accuracy.Verify corrective actions meet reliability standards and maintain proper documentation.Perform data analysis, record keeping, and ensure data integrity in line with regulatory requirements.Follow all site procedures related to GMP and safety practices.Skills/Experience required as a Sterilization Validation Engineer I Bachelor's degree in engineering or relevant field1-2 years' experience working within validation.Excellent knowledge of GMPKnowledge of industry appropriate ISO/EN standardsKnowledge of Sterility Assurance or Microbiology (Endotoxin, Bioburden etc)Knowledge of CAPAWhat is on offer as Sterilization Validation Engineer I High-Rate DOE12-month contractGain experience in leading Medical deviceWhat's Next Apply now by clicking the "Apply Now" button or call Elaine McCarthy at +353 21 4847135.
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