At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary
The Senior Validation Engineer is responsible for leading and overseeing customer and site validation activities to ensure sterilisation processes meet regulatory, quality, and customer requirements. This role manages complex validation projects, supports audits, mentors validation team members, and acts as a technical and operational delegate for the Regional Senior Validation Manager. The Senior Validation Engineer works closely with cross‑functional teams and customers to ensure compliant, efficient, and high‑quality validation operations in line with ISO standards, regulatory expectations, and STERIS business objectives.
Duties
- Collaborates with Customers throughout all stages of validation projects to establish cycle process parameters in compliance with ISO 11135. Coordinates validation cycles and reviews and approves validation protocols, reports, and CSPs within agreed timelines.
- Liaises with quality, operations, planning, laboratory, and customer service teams to coordinate and complete customer validation projects.
- Prepares for, supports, and facilitates internal and external audits by Customers, notified bodies, and Regulatory Agencies. Implements corrective actions for assigned audit findings.
- Conducts internal audits of the quality management system and reports findings, observations, and improvement opportunities.
- Schedules, documents, and coordinates commissioning and recommissioning of sterilisation chambers.
- Provides and facilitates departmental, cross-functional, and customer training related to technical expertise.
- Complies with STERIS core values, Code of Business Conduct, Global Work Instructions and local policies and procedures.
- Complies with health and safety requirements and promptly reports risks or breaches.
- Facilitates training, mentoring, and development of Validation Engineers and Validation Assistants.
- Partners with management to implement corrective actions and prevent non-conformances.
- Performs other site-specific duties assigned by the Regional Senior Validation Manager.
Duties - cont'd
Education Degree
Bachelor's Degree in Chemistry or Chemical Engineering
Required Experience
Minimum of 3-5 years of experience in Validation or Senior Engineer role with ISO 11135 and ISO 13485 - compliant medical device or regulated manufacturing environment experience.
Strong problem-solving and analytical skills.
Effective communication skills, both verbal and written.
STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.
STERIS strives to be an Equal Opportunity Employer.
