Manager (Gas Technology)

Position Summary

Management of the site ethylene oxide (EO) and vaporized hydrogen peroxide (VHP) Gas Technology Centre (GTC), ensuring that all Gas R&D activities are carried out in accordance with Customer requirements, STERIS policies & procedures, relevant international standards, directives, and regulations.

Manages a technology team as a Customer Service, Technical Support, and Profit Center for Gas processes.

The person in this role will be recognized as the primary subject matter expert & leader in their region regarding Gas R&D and process definition in accordance with regulatory requirements.

Responsible for all Customer-focused technical support, including direct Customer project management, supporting sales, marketing, production, Customer service, adherence to regulatory agency, ISO 9001 and Quality System policies and procedures. Duties include employee relations, administration, safety, and team performance.

Provides a broad range of technical, physical and regulatory support to internal and external Customers.

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, and Continuous Improvement / Lean initiatives.

Duties

Gas Technical Support & Guidance (40%)

• Manages and administers current and new business activities by developing plans and strategies to meet Customer requirements and maximize profit; providing current or prospective Customers tours of the facility; providing technical and project management services as needed; managing technical activities and providing coordination for evaluation of potential new products; working closely with contract laboratories and other resources to provide value-added services.
• High-level Customer-facing activities to discuss potential avenues for Gas sterilization research & development.
• Regularly interfaces with Customers to ensure service levels and expectations are met in partnership with commercial / sales leadership – participates in business reviews (where required).
• Educates and promotes technical solutions offering to Customers
• Ensures the EO GTC chamber is appropriately qualified / re-qualified in compliance with STERIS procedures, EN1422 and ISO 11135.
• Ensures the VHP GTC chamber is appropriately qualified / re-qualified in compliance with STERIS procedures, EN17180, and ISO 22441.
• Where required, ensures the operation of the data logger system (e.g. Pyrobutton, MadgeTech, etc.) for the GTC is maintained, so that all loggers used in R&D activities are within calibration.
• 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 Tech Team leaders.
• Supports marketing team with Customer seminars and educational activities e.g. Tech talks and Tech tips as required and appropriate.
• Support Quality Team in document review (qualification, WI) and in technical assessment of critical suppliers.
• Technical support and advice to other departments as required, e.g. quality audits, root cause investigations, trouble shooting, etc.

Duties - cont'd

Manages and coordinates the day-to-day activities of the GTC team (30%)

• Leads GTC team to perform according to the guidelines outlined in the STERIS Code of Business Conduct.
• Ensures the GTC is resourced with technically competent and trained personnel.
• Provide support and guidance to their direct reports.
• Reporting on GTC KPIs.
• Objective setting and providing critical feedback for team members to align with business KPIs.
• 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 GTC.
• Managing activities designed to achieve and maintain high employee morale; fostering intra- and inter-department cooperation.
• Minimizes and resolves internal or external business-related complaints by maintaining liaison with corporate counsel.

Duties - Cont'd

Regulatory Compliance (10%)

•  Ensure that all technical procedures and work instructions (local and global) are fully implemented and complied with.
• Ensures that R&D activities are carried out in accordance with STERIS procedures and in compliance with relevant international standards, directives and regulations.
• As a Gas sterilization subject matter expert (SME), 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 a Gas SME, support other STERIS departments including QA with compliance as required e.g. technical review and advice of NCs.
• Thorough review of all reporting and transactional procedures, ensuring the integrity and compliance of financial reporting and transactional procedure in support of Sarbanes-Oxley, section 404.

Duties - Cont'd

Training and Development (15%)

• Establishes an organizational structure by assigning responsibilities, delegating authority and selecting, orienting and training direct reports.
• Recruitment, training and performance management reviews of direct reports within the GTC team.
• Develops direct reports and ensures tools are in place to foster succession planning.
• Responsible for employee performance management of direct reports
• Manages their individual and team’s training and development; identifies training and development opportunities; maintains professional skills and knowledge by attending training and development sessions. 
• Develops training plans according to the growth and maturity of the GTC, in alignment with Job Descriptions.
• Documents and files training records and certifications. 

Duties - cont'd

Continuous Improvement (5%)

• Actively participates in STERIS ongoing 5S, lean and continuous improvement initiatives. 
• Actively supports the GTC team in identifying and implementing improvement initiatives.
• Identifies lean and continuous improvement opportunities and where feasible initiates or supports plan to implement improvement.
• Identifies opportunities for improvement of existing procedure documentation for the GTC.

General

• Contributes to a team effort by performing according to the guidelines outlined in the STERIS Code of Business Conduct, the QSR and other directives; supports the directives and decisions of higher-level management and accomplishes other duties as assigned.
• Communicates effectively by using accepted business practices courteously and professionally, providing timely and accurate responses, and service-oriented offers of assistance.
• Protects company confidential information by properly storing, retrieving and disseminating such information only to those authorized.
• Supports The STERIS AST business imperatives of Safety, Quality, Innovation, Sustainability and Lean and Customer Focus by acting 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.

Education Degree

Required Experience

• Diploma/Degree in life-science subject or Engineering along with relevant work-related experience in industrial sterilization: EO, steam, irradiation, VHP. 
• A minimum of 5 years’ industrial experience in sterilization with comprehensive knowledge of relevant standards both technical and quality.  
• Ability to effectively read, write and verbally communicate in English
• Ability to work under general direction of direct Supervisor
• Ability to work well with others
• Ability to adapt to changing duties and responsibilities
• Knowledge of EO sterilization and validation in accordance with ISO11135 and ISO22441 respectively
• Strong technical and problem-solving skills
• Working knowledge of relevant ISO standards and guidance documents
• Ability to demonstrate mathematical and technical competence for problem solving
• Able to complete statistical and data analysis using statistical tools such as MS Excel
• Excellent organizing skills and attention to detail
• Academic knowledge of Quality Systems and working in a regulated environment
• Gas Process & Technical Knowledge - Demonstrates solid proficiency and understanding of ISO 11135, 22441 and other ISO standards relating to the 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 is able to 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