Process Engineer, Validation

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, Validation is primarily responsible for leading and executing validation activities associated with introduction of New Product Ranges and changes to the current medical device. They will also support changes required by the contract design manufacturing organization (CDMO).

The Process Engineer, Validation will play a critical role in ensuring that all manufacturing processes, equipment, and test methods are validated in accordance with internal quality standards and external regulatory requirements. Working closely with cross-functional teams—including Quality, Regulatory, R&D, and Manufacturing—as well as external partners, the Validation Engineer will ensure that all validation deliverables are completed accurately, efficiently, and on schedule. This position is essential to supporting the company’s strategic manufacturing goals and maintaining the highest standards of product quality and compliance.

The Process Engineer, Validation 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 Snr. TT Lead (Sustain) and the CI & NPI (TT) Manager, the Process Engineer, Validation will be responsible for:

• Collaborating with the TT Engineers (Sustain) to ensure generation of compliant processes for new products and when implementing changes to existing ones.
• Develop and execute validation strategies for manufacturing processes and equipment.
• Author and review validation protocols and reports (IQ/OQ/PQ) for equipment, utilities, and processes.
• Coordinate and oversee both internal validation activities and external ones at manufacturing sites, ensuring alignment with internal standards.
• Support in the creation of technical documentation, including process maps, control plans, and test methods.
• Conduct risk assessments (e.g., FMEA) and support mitigation planning for validation-related risks.
• Ensure validation documentation is audit-ready and compliant with GMP and ISO 13485 requirements.
• Collaborate with Quality Assurance and Regulatory Affairs to support regulatory submissions and inspections.
• Participate in cross-functional meetings to provide validation updates, timelines, and risk assessments.
• Contribute to continuous improvement of validation procedures, templates, and best practices.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies

Requirements:
Skills & Experience

• Demonstrable experience in validation engineering within the medical device, pharmaceutical, or biotech industry.
• Experience supporting technology transfer projects and working with external manufacturing partners (preferred).
• Strong knowledge of validation principles, including IQ/OQ/PQ, process validation, and test method validation.
• Experience in medical device manufacturing or other regulated industries (e.g., pharma, biotech).
• Familiarity with ISO 13485, ISO 14971, FDA 21 CFR Part 820, and other relevant regulatory standards.
• Knowledge of statistical tools and software used in validation and process analysis (e.g., Minitab, JMP).
• Proficiency in writing and reviewing technical documentation, including protocols, reports, and SOPs.
• Experience with risk management tools such as FMEA, control plans, and root cause analysis.
• Ability to manage multiple validation 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 process, manufacturing, mechanical, biomedical or other relevant discipline) or experience in the medical device industry (or a comparably highly regulated industry)
• Certification in Lean, Six Sigma, or validation-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.