ABOUT ORGANOX:

OrganOx is a commercial stage organ technology company dedicated to developing technologies to improve outcomes for patients with acute or chronic organ failure. The company was established as a spin out of the University of Oxford in 2008 and is now part of the Terumo Group. OrganOx is a pioneer in normothermic machine perfusion (NMP). It's flagship platform, the metra®, is available for use in the U.S., Europe, Canada, and Australia. It has been utilized in over 7,000 liver transplants to date to keep donor livers in a metabolically active state outside the body enabling longer preservation times and functional assessment of the organ prior to transplant, leading to an increased number of organs available for transplant. Founded in 1921, Terumo Corporation (TSE:4543) strives to fulfil its mission of "Contributing to Society through Healthcare" by providing a comprehensive range of solutions in the fields of therapeutic procedures, hospital operations, and life sciences in more than 160 countries and regions.

Position Summary

The Process Engineer, Packaging is responsible for designing, developing, and validating packaging solutions for new and existing medical device products. They will ensure that all packaging systems meet regulatory requirements, maintain product integrity, and support efficient manufacturing and distribution processes.

Working closely with cross-functional teams-including Quality, Regulatory, R&D, and Manufacturing-as well as external suppliers and contract manufacturing organisations (CMOs), this individual will play a critical role in ensuring packaging compliance, sustainability, and cost-effectiveness. This position is essential to supporting the company's strategic goals for product quality, patient safety, and operational excellence.

The Process Engineer, Packaging will primarily work at OrganOx's Oxford site, with occasional travel to supplier & CDMO sites, and some opportunity to work from home as appropriate.

Listed below are the major responsibilities of the role and a brief description of some of the key tasks to be performed. This list is not totally exhaustive.

Major Responsibilities

Under direction from the CI & NPI (Tech Transfer) Manager, the Process Engineer, Packaging will be responsible for:

• Designing and developing packaging solutions for medical devices, ensuring compliance with ISO 11607 and other relevant standards.
• Leading packaging validation activities, including writing and executing protocols (IQ/OQ/PQ) for packaging processes and equipment.
• Collaborating with R&D and Manufacturing to ensure packaging designs meet functional, regulatory, and cost requirements.
• Creating and maintaining packaging specifications, drawings, and bills of materials.
• Performing transit and distribution testing (ISTA, ASTM) to ensure packaging integrity throughout the supply chain.
• Supporting sustainability initiatives by evaluating and implementing eco-friendly packaging materials and processes.
• Conducting risk assessments (e.g., FMEA) for packaging-related processes and implementing mitigation strategies.
• Ensuring packaging documentation is audit-ready and compliant with GMP and ISO 13485 requirements.
• Working with suppliers and CMOs to qualify packaging components and processes.
• Participating in cross-functional meetings to provide packaging updates, timelines, and risk assessments.
• Driving continuous improvement in packaging design, validation, and documentation practices.
• Adhere to the letter and spirit of OrganOx's Code of Conduct and all other company policies

Requirements

Skills & Experience

• Demonstrable experience in packaging engineering within the medical device, pharmaceutical, or biotech industry.
• Strong knowledge of packaging engineering principles and materials science.
• Experience in medical device packaging or other regulated industries (e.g., pharma, biotech).
• Familiarity with ISO 11607, ISO 13485, FDA 21 CFR Part 820, and other relevant regulatory standards.
• Experience with packaging validation and distribution testing (ISTA, ASTM).
• Knowledge of CAD software and packaging design tools.
• Proficiency in writing and reviewing technical documentation, including protocols, reports, and SOPs.
• Experience with risk management tools such as FMEA and control plans.
• Ability to manage multiple packaging projects simultaneously in a fast-paced environment.
• Strong communication and interpersonal skills for effective collaboration with internal and external stakeholders.
• Detail-oriented with a commitment to quality, compliance, and continuous improvement.

Qualifications

• A degree/equivalent qualification in packaging engineering, materials science, mechanical engineering, or a related discipline (essential).
• Certification in Lean, Six Sigma, or packaging-related training (desirable).

Benefits

At OrganOx, we value innovation, evidence, integrity, teamwork, respect, and passion. We offer competitive compensation and comprehensive benefits, including healthcare and retirement plans. We support work-life balance and provide opportunities for ongoing professional development.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, disability, gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation race, or any other characteristics protected by law.