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 field
- 1-2 years’ experience working within validation.
- Excellent knowledge of GMP
- Knowledge of industry appropriate ISO/ EN standards
- Knowledge of Sterility Assurance or Microbiology ( Endotoxin, Bioburden etc)
- Knowledge of CAPA
What is on offer as Sterilization Validation Engineer I
- High-Rate DOE
- 12-month contract
- Gain experience in leading Medical device
What’s Next
Apply now by clicking the "Apply Now" button or call Elaine McCarthy at +353 21 4847135. If this job isn’t quite right but you’re looking for something similar, please get in touch. We also have multiple temporary, FTC, and contract jobs available
