Validation Technician

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.Position Summary As a member of the EO Technical Team the Validation Technician works as directed by their direct Supervisor to facilitate and support Customer qualifications in both EO and VHP. Carries out all aspects of their role and associated documentation in compliance with STERIS Quality Management System, ISO11135, ISO13485, ISO22441 and FDA regulatory requirements while adhering to GMP and GDP requirement. Proactively supports their direct Supervisor to successfully achieve departmental goals and STERIS objectives. Establishes strong functional and cross functional Customer relations and provides exceptional Customer service to ensure requirements of their role are being met. Collaborates with EO Tech Team to support the establishment of best practice approach through knowledge and idea sharing. DutiesSpecific duties/responsibilities (60–70%) Works as directed by direct Supervisor to facilitate and support Customer qualifications within the EO and VHP Technical department. Carries out all aspects of their role and associated documentation in compliance with STERIS Quality Management System, ISO11135, ISO13485, ISO22441 and FDA regulatory requirements while adhering to GMP and GDP requirement. Complies with local and global procedures. Facilitates VHP processing of Customer batches, performs inspections of batches, load set up, processing of Customer batches and completes all associated documentation. Operates the VHP Sterilizer and conducts regular checks to verify conformance to specification and check alarms, taking appropriate action as needed. At all times performs all tasks in adherence with safety and environmental policies and procedures. Completes qualification batch records in compliance to GDP and GMP, demonstrating a high level of attention to detail. Reviews qualification batch records for compliance to GDP and GMP, demonstrating a high level of attention to detail. Follows up with Operations to address and close out on any batch record queries within agreed timelines. Duties - cont'd Provides administration support to the EO Tech Team. Completes filing and archiving of qualification batch records and supporting EO qualification documentation. Sets and agrees annual GPS performance objectives with direct Supervisor. Actively participates in performance management reviews in line with STERIS corporate requirements and timelines. Actively participates in project Teams as agreed with direct Supervisor. Other site-specific duties and/or responsibilities as assigned by direct Supervisor. Where applicable to site EO Tech Team; Using dedicated datalogger software performs the following tasks Launching of dataloggers for use in scheduled qualification cycles. Providing Operations with dataloggers as and when required Downloading and analysing of datalogger data. Conducting verification and/or Calibration of dataloggers. Duties - contdRegulatory Compliance (5 -10%) •Prepares for and provides audit support to the Quality department during internal, Customer and regulatory audits. •Supports direct Supervisor in the close out of audit findings and recommendations pertaining to VHP and EO TechTeam. •Supports root cause investigations and implementation of appropriate corrective and preventative actions in conjunction with the site Quality Manager and direct Supervisor. Where applicable, •Conducts internal audits of the quality management system, identifies, documents and reports audit findings, observations, recommendations for improvement or non-conformances. Training and Development (5%) •Manages their individual training and development, identifies training and development opportunities, maintains professional skills and knowledge by attending training and development sessions. •Documents and files training records and certifications. Continuous Improvement (5%) •Actively participates in STERIS ongoing 5S, lean and continuous improvement initiatives. •Actively supports the EO TechTeam in identifying and implementing improvement initiatives. •Identifies lean and continuous improvement opportunities and where feasible initiates or supports plan to implement improvement.Duties - contdEO Tech Team Support & collaboration (10-20%) •Provides input and review on local work instruction/ procedures to ensure alignment and adherence can be achieved. •Provides on the job training in area of technical expertise as requested by direct Supervisor. •Supports harmonization through sharing knowledge and ideas to achieve common objectives and ensure best practice approach is employed. •Identifies opportunities for improvement and as agreed with direct Supervisor, implements improvements in line with best practice. •Collaborates and regularly interacts with direct Supervisor to ensure role requirements and expectations are being met. •Seeks advice, support, and input from direct Supervisor when needed to establish best practice approach. •Under Supervisor guidance, applies technical knowledge and experience to make informed decisions and ensure best practice approach is employed. •Collaborates and proactively supports direct Supervisor to achieve STERIS goals and objectives. •Performs according to the guidelines outlined in the STERIS Code of Business Conduct. Supports STERIS AST business imperatives of Safety, Quality, Customer Focus, Innovation, Sustainability and Lean. •Collaborates with all STERIS employees, Customers, auditors, and visitors to the site in a professional, constructive, and respectful manner. Encourages open communication providing timely and accurate responses. •Complies with Health and safety polices & procedures, reports any concerns, potential risks or hazards to the Health and Safety representative so appropriate action can be taken.Education DegreeRequired Experiencedge of EO sterilization or VHP Sterilization and validation in accordance with ISO11135 and ISO22441 respectively technical and problem-solving skills ent attention to detail displaying exceptional GDP and GMP. g knowledge of relevant ISO standards and guidance documents ient in use of MS Office with ability to complete data analysis using Microsoft excel Specific Work Preferences 1. Ability to effectively read, write and verbally communicate in English. 2. Ability to work under general direction of direct Supervisor. 3. Ability to work autonomously 4. Ability to work well with others. 5. Excellent organizing skills and attention to detail. 6. Ability to adapt to changing duties and responsibilities. 7. Normal hearing range sufficient to hear alarms, bells, horns, etc.Competencies STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries. STERIS strives to be an Equal Opportunity Employer.