Validation Manager

Position Summary

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%)

• Directs and supports the regional business in matters such as harmonized policy and procedure development; best practice sharing; training & development initiatives.
• Ensure harmonization across STERIS sites in EMEA APAC region by collaborating with other EO TechTeam leaders.
• 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. Tech talks and Tech tips as required and appropriate.
• 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).
• Technical support and advice to other departments as required.

Manages and coordinates the day‑to‑day activities of site EO TechTeam. (25%)

• Leads EO TechTeam to perform according to the guidelines outlined in the STERIS Code of Business Conduct.
• Ensures the EO TechTeam is resourced with technically competent and trained personnel. Implement training plans in accordance with competency framework aligned to Job Descriptions.
• Drives a culture of positive employee relations, including responsiveness to safety, employee relations issues, disciplinary actions, communicating clear expectations and accountability processes, demonstrating effective leadership of the site EO TechTeam.
• 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. Pyrobutton, MadgeTech, etc.) for the site is maintained so that all loggers used in validation activity are within calibration.

EO Regulatory compliance (15%)

• 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.

Technology development and Innovation (10%)

• Facilitates and promotes the advancement of the STERIS SEO program through activities such as Cycle Calculation and/or Parametric Release.
• Educates