**About Sigmar Recruitment**
We are seeking a detail-oriented Sterilization Validation Engineer I to join our team at a leading medical device company in Galway. This is a 12-month contract position.
As a Sterilization Validation Engineer I, you will play a key role in supporting critical sterility assurance activities and ensuring the highest standards of quality and compliance across manufacturing and product development processes.
Your Responsibilities:
* 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.
Requirements:
* Bachelor's degree in engineering or relevant field.
* 1-2 years experience working within validation.
* Excellent knowledge of GMP.
* Knowledge of CAPA.
About the Role:
* High-Rate DOE 12-month contract.
* Gain experience in leading Medical device projects.