Validation Manager

Position Summary

We are looking for a candidate that will join our team as a Validation Manger.

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.

Duties

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 respectexhibiting 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 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.

Duties (continued)

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 and promotes technical solutions offering to Customers
• Facilitate & support EO focused R&D initiatives as required e.g. cycle design aeration optimization.

Education Degree

Minimum Work Experiance

• 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: EO steam irradiation VHP.

Specific Work Requirements

• 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; attention to detail.
• Knowledge of EO sterilization and validation in accordance with ISO11135
• Strong technical writing scientific writing and problem-solving skills
• Sound understanding of research methodologies
• 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

Specific Work Preferences

• Ability to demonstrate mathematical and technical competence for problem solving.
• Excellent organizing and analysing skills with ability to determine organizational 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.
• Ability to adapt to changing duties and responsibilities.
• Academic knowledge of Quality Systems and working in a regulated environment.
• Academic knowledge of Good Documentation Practices (GDP)
• Normal hearing range sufficient to hear alarms bells horns etc.

Specific Skills

• EO Process & Technical Knowledge - Demonstrates solid proficiency and understanding of ISO11135 and other ISO standards relating to the EO sterilization of medical devices
• Initiative/Leadership - Self-starter takes charge with little direction seeks clarification if unsure of direction Proactively voices ideas opinions and recommendations in a constructive way
• Customer Focus - Demonstrate a Customer first always mind set and a passion for serving each Customer by listening and identifying their needs.
• Teamwork - Builds constructive and effective relationships and effectively manages through conflict while maintaining relationships.
• Communication - Clear concise communicator who can clearly express opinions and ideas while maintaining trust and credibility.
• Job Knowledge/Business Acumen - Demonstrates solid proficiency in job function and understands how his/her position impacts the organization

Compensation

In line with our commitment to transparency and equal pay we provide the following information:

• Salary Range: 60.000 65.000 gross per year
• NCBA: Gomma e Plastica Industria
• Bonus: This position is eligible for corporate bonus .