Validation Manager

<div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Position Summary</H2></div><div><p>We are looking for a candidate that will join our team as a Validation Manger.</p><p>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.</p><p>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.</p><p>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.</p></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Duties</H2></div><div><p><strong>EO Technical Support & Guidance</strong> <strong>(30%)</strong></p><ul><li>Directs and supports the regional business in matters such as harmonized policy and procedure development; best practice sharing; training & development initiatives.</li><li>Ensure harmonization across STERIS sites in EMEA APAC region by collaborating with other EO TechTeam leaders</li><li>As the most senior technical person in the region, provide high-level external support to Customers as required.</li><li>Supports marketing team with Customer seminars and education activities e.g. Tech talks and Tech tips as required and appropriate.</li><li>Ensure that all technical procedures and work instructions (local and global) are fully implemented and complied with.</li><li>Support Customer qualification activities to ensure they are performed according to relevant standard requirements.</li><li>Facilitates training of EO TechTeam members.</li><li>Support Quality Team in document review (qualification, WI) and in technical assessment of critical suppliers.</li><li>Regularly interfaces with Customers to ensure service levels and expectations are met in partnership with commercial / sales leadership – participates in business reviews (where required).</li><li>Technical support and advice to other departments as required.</li></ul><p><strong>Manages and coordinates the day-to-day activities of site EO TechTeam. (25%)</strong></p><ul><li>Leads EO TechTeam to perform according to the guidelines outlined in the STERIS Code of Business Conduct.</li><li>Ensures the EO TechTeam is resourced with technically competent and trained personnel.

Implement training plans in accordance with competency framework aligned to Job Descriptions.</li><li>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.</li><li>Supports The STERIS AST business imperatives of Safety, Quality, Innovation, Sustainability and Lean and Customer Focus.</li><li>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.</li><li>Recruitment, training and performance management reviews of direct reports within the EO TechTeam.</li><li>Develops direct reports and ensures tools are in place to foster succession planning.</li><li>Responsible for employee performance management of direct reports</li><li>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.</li></ul><p><strong>Operational Qualification and Annual Requalification of EO Processing Equipment (20%)</strong></p><ul><li>Ensure EO processing equipment is appropriately qualified / re-qualified in compliance with STERIS procedures, EN1422 and ISO 11135.</li><li>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.</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Duties (continued)</H2></div><div><p><strong>EO Regulatory compliance (15%)</strong></p><ul><li>As an EO subject matter expert represent STERIS as required at relevant CEN and ISO standards and/or national mirror bodies.</li><li>Support STERIS regulatory with implementation of regulatory facing activities such as FDA Master File</li><li>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.</li></ul><p><strong>Technology development and Innovation (10%)</strong></p><ul><li>Facilitates and promotes the advancement of the STERIS SEO program through activities such as Cycle Calculation and/or Parametric Release.</li><li>Educates and promotes technical solutions offering to Customers</li><li>Facilitate & support EO focused R&D initiatives as required e.g. cycle design, aeration optimization.</li></ul><p> </p></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Education Degree</H2></div><ul style='margin-top: 0;margin-bottom: 0;' ><li>Bachelor's Degree in Engineering General or Science</li></ul></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Minimum Work Experiance</H2></div><div><ul><li>A minimum of 5 years’ industrial experience in sterilization with comprehensive knowledge of relevant standards both technical and quality. </li><li>Diploma/Degree in life-science subject or Engineering along with relevant work-related experience in industrial sterilization: EO, steam, irradiation, VHP. </li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Specific Work Requirements</H2></div><div><ul><li>Ability to effectively read, write and verbally communicate in English.</li><li>Ability to work under general direction guidance and leadership of a Supervisor or Director.</li><li>Ability to work well with others.</li><li>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; attention to detail.</li><li>Knowledge of EO sterilization and validation in accordance with ISO11135</li><li>Strong technical writing, scientific writing and problem-solving skills</li><li>Sound understanding of research methodologies</li><li>Ability to complete statistical and data analysis</li><li>Working knowledge of other relevant ISO standards and guidance documents (ISO10993-7, ISO 11737-1, ISO11138 series, ISO11137 series, EN 1422)</li><li>Proficient in use of MS Office and statistical tools</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Specific Work Preferences</H2></div><div><ul><li>Ability to demonstrate mathematical and technical competence for problem solving.</li><li>Excellent organizing and analysing skills with ability to determine organizational, Customer and regulatory problems and formulate corrective action plans.</li><li>Proficient in use of MS Excel, MS Word, MS PowerPoint.

Able to complete statistical and data analysis using statistical tools such as MS Excel.</li><li>Ability to adapt to changing duties and responsibilities.</li><li>Academic knowledge of Quality Systems and working in a regulated environment. </li><li>Academic knowledge of Good Documentation Practices (GDP)</li><li>Normal hearing range sufficient to hear alarms, bells, horns, etc.</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Specific Skills </H2></div><div><ul><li><strong>EO Process & Technical Knowledge -</strong> Demonstrates solid proficiency and understanding of ISO11135 and other ISO standards relating to the EO sterilization of medical devices</li><li><strong>Initiative/Leadership</strong> - Self-starter takes charge with little direction, seeks clarification if unsure of direction Proactively voices ideas, opinions, and recommendations, in a constructive way</li><li><strong>Customer Focus - </strong>Demonstrate a “Customer first, always” mind set and a passion for serving each Customer by listening and identifying their needs.</li><li><strong>Teamwork - </strong>Builds constructive and effective relationships and effectively manages through conflict while maintaining relationships.</li><li><strong>Communication - </strong>Clear, concise communicator who can clearly express opinions and ideas while maintaining trust and credibility.</li><li><strong>Job Knowledge/Business Acumen</strong> - Demonstrates solid proficiency in job function and understands how his/her position impacts the organization</li></ul></div></div><div style='padding: 10px 0px;border: 1px solid transparent;'><div style='font-size:16px;word-wrap: break-word;'><H2 style='font-size: 1em; margin: 0px'>Compensation</H2></div><div><p>In line with our commitment to transparency and equal pay, we provide the following information:</p><ul type="disc"><li><strong>Salary Range:</strong> €60.000 – € 65.000 gross per year</li><li><strong>NCBA: </strong>Gomma e Plastica Industria</li><li><strong>Bonus:</strong> This position is eligible for corporate bonus .</li></ul></div></div></div> <p>STERIS strives to be an Equal Opportunity Employer. </p>