Validation Manager
Pubblicato il 23-10-2026 - Steris in Italia
We are looking for a candidate that will join our team as a Validation Manager. Management of the site EO TechTeam, ensuring that all EO validation activities are carried out in accordance with Customer requirements, STERIS policies & procedures, relevant international standards, directives, and regulations. Person in this role will be recognized as the primary subject matter expert & leader in their region regarding EO sterilization technology including equipment and process qualification in accordance with regulatory requirements. An integral member of the local management team, the role also supports other departments, including but not limited to quality and regulatory inspections, root cause investigations, qualification and requalification of EO processing equipment and Continuous Improvement / Lean initiatives. EO Technical Support & Guidance (30%) training & development initiatives. As the most senior technical person in the region, provide high‑level external support to Customers as required. Supports marketing team with Customer seminars and education activities e.g. Ensure that all technical procedures and work instructions (local and global) are fully implemented and complied with. Support Customer qualification activities to ensure they are performed according to relevant standard requirements. Facilitates training of EO TechTeam members. Support Quality Team in document review (qualification, WI) and in technical assessment of critical suppliers. Regularly interfaces with Customers to ensure service levels and expectations are met in partnership with commercial / sales leadership – participates in business reviews (where required). Ensures the EO TechTeam is resourced with technically competent and trained personnel.
Implement training plans in accordance with competency framework aligned to
Job Description
s. Supports the STERIS AST business imperatives of Safety, Quality, Innovation, Sustainability and Lean and Customer Focus. Acts with integrity, treating everyone with mutual respect, exhibiting a genuine commitment to the success of all employees, and delivering satisfaction to our Customers through teamwork, innovation and continuous improvement. Recruitment, training and performance management reviews of direct reports within the EO TechTeam. Develops direct reports and ensures tools are in place to foster succession planning. Responsible for employee performance management of direct reports. Allocation of Customer validation and/or equipment qualification activities to the site EO TechTeam. Ensures Qualifications are carried out in accordance with STERIS procedures and in compliance to relevant international standards, directives and regulations. Operational Qualification and Annual Requalification of EO Processing Equipment (20%) Ensure EO processing equipment is appropriately qualified / re‑qualified in compliance with STERIS procedures, EN1422 and ISO 11135. Where required, ensuring the operation of the data logger system (e.g. As an EO subject matter expert represent STERIS as required at relevant CEN and ISO standards and/or national mirror bodies.
Support STERIS regulatory with implementation of regulatory facing activities such as FDA Master File. As an EO SME support other STERIS departments including QA with EO compliance as required e.g. technical review of NCs (RCA, Corrective Action) & Change control. Educates and promotes technical solutions offering to Customers. Education Degree ~ Bachelor's Degree in Engineering General or Science. Minimum Work Experience A minimum of 5 years’ industrial experience in sterilization with comprehensive knowledge of relevant standards both technical and quality. Diploma/Degree in life‑science subject or Engineering along with relevant work‑related experience in industrial sterilization: Ability to effectively read, write and verbally communicate in English. Ability to work under general direction guidance and leadership of a Supervisor or Director. Ability to work well with others. Above average organizing, analysing and math skills (advanced algebra and/or calculus and/or statistics) to determine organizational, Customer and regulatory problems and formulate corrective action plans; Strong technical writing, scientific writing and problem‑solving skills. Ability to complete statistical and data analysis. Working knowledge of other relevant ISO standards and guidance documents (ISO10993‑7, ISO 11737‑1, ISO11138 series, ISO11137 series, EN 1422). Proficient in use of MS Office and statistical tools. Excellent organising and analysing skills with ability to determine organisational, Customer and regulatory problems and formulate corrective action plans. Proficient in use of MS Excel, MS Word, MS PowerPoint. Able to complete statistical and data analysis using statistical tools such as MS Excel. Academic knowledge of Quality Systems and working in a regulated environment.