Calibration/Steam Sterilisation Qualification Specialist

Vantive; Castlebar; On-site; EUR 40,000 - 65,000; Full time

Job summary

Vantive, a vital organ therapy company in Castlebar, seeks a Calibration & Sterilisation Qualification Specialist to join our Quality team. You will support calibration programs, sterilisation qualification studies, and QA reviews to ensure product safety and compliance.

The role involves cross-functional collaboration with Quality, Engineering, Operations, and Maintenance, managing calibration systems, and contributing to continuous improvement initiatives while upholding EHS and regulatory

Qualifications

• Third-level qualification in Engineering, Science, Quality, Manufacturing, or a related technical discipline.
• 2–4 years of experience in calibration, sterilisation, validation, engineering, maintenance, or quality within a regulated manufacturing environment.
• Strong technical aptitude with analytical and problem-solving skills.
• Experience in 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 cross-functional collaboration.
• Proficiency in Microsoft Office and calibration management systems.

Responsibilities

• Support safety culture and EHS policies.
• Perform calibration, maintenance, and verification of measurement and test equipment.
• Set up and operate calibration/test equipment for instruments used in manufacturing and quality processes.
• Troubleshoot, adjust, and repair instruments to meet calibration requirements.
• Coordinate external calibration and recertification with labs and document reviews.
• Manage calibration scheduling and tracking systems.
• Execute routine calibration activities and maintain records.
• Lead steriliser qualification activities (installation, operation, performance).
• Review and approve sterilisation cycles and related documentation.
• Back up Sterility Assurance Engineer and assess quality impact of deviations.
• Participate in continuous improvement to enhance reliability and compliance.
• Assist with regulatory inspections and internal audits.

Skills

Analytical skills

Problem solving

Attention to detail

Cross-functional collaboration

Communication skills

Microsoft Office

Education

Third-level qualification in Engineering, Science, Quality, Manufacturing, or related discipline

2–4 years in calibration, sterilisation, validation, engineering, maintenance, or quality in regulated manufacturing

Tools

Calibration management systems

Job description

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.