GTC Technician I

Position Summary

As a member of the Gas Technology Centre Team, the GTC Technician I works as directed by their line manager to facilitate and support Customer trial and development work with both Ethylene Oxide (EO) and Vapourised Hydrogen Peroxide (VHP).

The successful candidate will carry out all aspects of their role and associated documentation in compliance with STERIS Quality Management System, ISO11135, ISO22441, ISO13485 and FDA regulatory requirements while adhering to GMP and GDP requirement.

Proactively support their line manager 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 and Operations department to support the establishment of best practice approach through knowledge and idea sharing.

Duties

• Works as directed by line manager to facilitate and support Customer (both internal and external) trial and development studies across both VHP and EO technologies.
• Carries out all aspects of their role and associated documentation in compliance with STERIS Quality Management System, ISO11135, ISO22441, ISO13485 and FDA regulatory requirements while adhering to GMP and GDP requirement. Complies with local and global procedures.
• Facilitates processing of Customer test batches, performs inspections of batches, load set up, processing of Customer batches and completes all associated documentation, with supervision.
• Performs the receipt of new product on site ensuring it matches the details of the Customer submission and all relevant information/documentation has been provided.
• Performs the scheduling of product within the VHP Sterilizer or EO R&D vessel as required, considering the Customer specification, the product configuration, the available capacity, other scheduled products and the working hours of the facility.
• Operates the VHP Sterilizer and EO R&D vessel and conducts regular checks to verify conformance to specification and check alarms, taking appropriate action as needed, with supervision.  
• At all times performs all tasks in adherence with safety and environmental policies and procedures.
• Completes batch records in compliance to GDP and GMP, demonstrating a high level of attention to detail.  
• Reviews 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.
• Report Writing (if applicable); Assists in the creation of protocols/reports with supervision.
• Performs the preparation of finished product for shipping by preparing any necessary documentation, product re-configuration/verification, and security of shipper.
• Completes filing and archiving of batch records and supporting EO qualification documentation.
• Sets and agrees annual GPS performance objectives with line manager.  Actively participates in performance management reviews in line with STERIS corporate requirements and timelines.
• Actively participates in project Teams as agreed with line manager.
• Other site-specific duties and/or responsibilities as assigned by line manager.

Duties - cont'd

• Provides on-the-job training in area of technical expertise as requested by line manager.  
• Identifies opportunities for improvement and, where agreed with line manager, implements improvements in line with best practice.
• Under manager’s guidance, applies technical knowledge and experience to make informed decisions and ensure best practice approach is employed. 
• Collaborates and proactively supports line manager 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.
• Provides audit support to the Quality department during internal, Customer and regulatory audits. 
• Manages their individual training and development, identifies training and development opportunities, maintains professional skills and knowledge by attending training and development sessions. 

Education Degree

Required Experience

• Associate Degree or Diploma level qualification in Technical / Engineering.
• Working knowledge of ISO13485, ISO11135, ISO22441 and EO or VHP sterilization knowledge desirable but not essential.
• In lieu of meeting the minimum educational requirement applicants with a minimum of 2 year’s industrial experience in industrial sterilization, demonstrating strong administration and technical skills with working knowledge of quality standards ISO11135, ISO22441 and ISO13485 will be considered.  
• Strong technical and problem-solving skills
• Good attention to detail displaying academic knowledge of GDP and GMP.
• Academic knowledge of relevant ISO standards and guidance documents

Competencies