Validation Supervisor

HOW YOU WILL MAKE A DIFFERENCE

About you:

Do you want to spend your working time making a difference in the world around you? Are you passionate about supporting the medical and pharmaceutical industries? Do you care about keeping patients and people safe? If so, then a career with Steris AST could be a great fit for you.

About Us:

At Steris AST we are the trusted experts in neutral sterilization offering includes radiation and gas technologies.

We offer electron beam, gamma, X-ray, ethylene oxide and vaporized hydrogen peroxide technologies for the purpose of product sterilization. Whether that product be a single use medical instrument, a hospital environment, cosmetics and toiletries, or food products, we make sure that everything that makes its way to an end user is safe for use or consumption.

We are currently recruiting for a Validation Supervisor vacancy. This is an excellent opportunity to join the business at a skilled professional level.

What is involved

Supervises and coordinates the day-to-day activities of direct reports (45%)

• Ensures direct reports perform according to the guidelines outlined in the STERIS Code of Business Conduct.
• Responsible for overseeing, supporting, and guiding the EO Technical Department throughout all stages of Customer validations to ensure all validation activities are performed as per the requirements of ISO 11135 and in line with Customer requirement.
• Sets and agrees annual GPS performance objectives with direct reports, schedules and conducts their performance management reviews and assigns performance ratings in line with STERIS corporate requirements and timelines.
• With support from EO Technical Manager agrees and facilitates training and developments plans for direct reports to achieve the required competency levels specific to their role.
• Identifies and addresses knowledge gaps and training needs within the department as agreed with EO Technical Manager.
• Maintains and encourages positive team morale, interacts with all STERIS employees in a constructive manner. Encourages open communication.
• Seeks input and deals with disciplinary issues as advised and supported by HR and EO Technical Manager.
• Supports and promotes STERIS AST business imperatives of Safety, Quality, Customer Focus, Innovation, Sustainability and Lean.
• Complies with Health and safety procedures at all times, reports any concerns, potential risks or hazards to the Health and Safety representative so appropriate action can be taken

EO Technical expertise & Guidance (30%)

• Shares Technical Expertise and knowledge across STERIS and with Customers. • Provides technical input and recommendations to facilitate harmonization and sharing of best practice across STERIS EMEA APAC region.
• Supports the Quality department with review of local and global work instruction and procedures providing input and recommendation to ensure alignment and adherence can be achieved.
• Supports EO Technical Manager in ensuring that all technical procedures and work instructions (local and global) are fully implemented and complied with.
• Provides Technical support to Customers. Regularly interfaces with Customers to ensure validation expectations are being met. Participates in Customer meetings and business reviews when required.
• Compiles training material and facilitates departmental, cross functional and Customer training in areas of technical expertise when requiredApplies technical expertise and knowledge to make informed decisions.
• Collaborates with Customers and provides technical input and expertise as required to ensure all aspects of their validation requirements are fully considered and can be met

EO Regulatory Compliance (10%)

• Provides support and facilitation as required to the Quality department during internal, Customer and regulatory audits.
• Support EO Technical Manager in tasks pertaining to the maintenance of site QMS, e.g. technical review and advice of NCs (RCA, Corrective Action), Change control

Operational Qualification and Annual Requalification of EO Processing Equipment (5%)

• Support EO Technical Manager to ensure EO processing equipment is appropriately qualified / re-qualified in compliance with STERIS procedures, EN1422 and ISO 11135.
• Support EO Technical Manager in 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.
• Works with responsible Engineer/Technician to ensure verification and calibration of dataloggers are completed accurately and within the required timeframe and sufficient stock of dataloggers are available to support ongoing validation requirements. Ensures datalogger calibrator is within calibration

Technology development and Innovation (5%)

• Supports the advancement of the STERIS SEO program through activities such as Cycle Calculation validation, Parametric Release.
• Educates and promotes technical solutions offering to Customers
• Provides technical supports and input for EO focused R&D initiatives as required e.g. cycle design, aeration optimization.

Continuous Improvement (5%)

• Champions and participates in STERIS ongoing 5S, lean and continuous improvement initiatives.
• Encourages and supports the EO TechTeam in identifying and implementing lean and continuous improvement initiatives.
• Identifies opportunities for improvements and using continuous improvement tools identifies and implements improvement.

Required experience and knowledge

• 5 years’ experience in highly regulated industry
• ISO knowledge within- 13485, 11135, 17025 or IATF
• Strong technical writing, scientific writing, and problem-solving skills
• Sound understanding of research methodologies 4. Ability to complete statistical and data analysis and validation
• Strong team leadership
• Ability to adapt to changing duties and responsibilities
• Ability to effectively read, write and verbally communicate in English.
• Ability to work under general direction of a supervisor or Manager
• Ability to work autonomously and to work well with others.
• Excellent project management and organisational skills.
• Excellent organizing, analysing and math skills to determine organizational, Customer and regulatory problems and formulate corrective action plans; attention to detail.
• 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.

Equal Opportunities

STERIS plc provides employment and advancement opportunities without regard to age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion/belief, sex (gender), sexual orientation or any other legally protected characteristic as defined by employment law. The Company bases all employment decisions on merit, qualifications, skills, and abilities with the intention that the best candidate is selected for each position.