Calibration/Steam Sterilisation Qualification Specialist

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

An exciting opportunity has arisen for a Calibration & Sterilisation Qualification Specialist to join our Quality team in Castlebar.

Reporting to the Microbiology, Sterility Assurance & Calibration Manager, you will play a key role in ensuring the ongoing compliance, reliability, and effectiveness of our calibration and sterilisation processes. Working cross-functionally with Quality, Engineering, Operations, and Maintenance teams, you will help maintain the highest standards of product quality and patient safety.

Duties and responisbilities:

• Support and promote a strong culture of safety by adhering to all Environmental, Health & Safety (EHS) policies, procedures, and regulatory requirements.
• Perform calibration, maintenance, and verification of measurement and test equipment in accordance with established standards and procedures.
• Set up and operate calibration and test equipment to evaluate the accuracy and performance of instruments used in manufacturing and quality processes.
• Troubleshoot, adjust, and repair instruments to ensure compliance with calibration requirements.
• Coordinate external calibration and recertification activities with approved standards laboratories, including documentation review and instrument inspections.
• Manage and maintain the site's calibration scheduling and tracking systems to ensure ongoing compliance.
• Execute routine calibration activities and maintain accurate calibration records.
• Lead and support steriliser qualification activities, including installation, operational, and performance qualification studies.
• Conduct Quality Assurance review and approval of sterilisation cycles and associated documentation.
• Serve as a backup to the Sterility Assurance Engineer, including assessing the quality impact of process deviations and non-conformances relating to sterilised product loads.
• Participate in continuous improvement initiatives to enhance equipment reliability, compliance, and operational efficiency.
• Collaborate with cross-functional teams to support regulatory inspections, internal audits, and compliance activities.
• Perform additional responsibilities as required to support business and quality objectives.

Education and experience:

• Third-level qualification in Engineering, Science, Quality, Manufacturing, or a related technical discipline preferred.
• 2-4 years of experience in a calibration, sterilisation, validation, engineering, maintenance, or quality role within a regulated manufacturing environment.
• Strong technical aptitude with excellent analytical and problem-solving skills.
• Experience working within GMP-regulated environments is desirable.
• Knowledge of calibration systems, metrology principles, or sterilisation processes would be advantageous.
• Strong attention to detail and commitment to quality and compliance.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficiency in Microsoft Office applications and experience with calibration management systems is desirable.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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