Validation Technician

at  Steris

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.

REQUIRED EXPERIENCE

1.Knowledge of EO sterilization or VHP Sterilization and validation in accordance with ISO11135 and ISO22441 respectively
2.Strong technical and problem-solving skills
3.Excellent attention to detail displaying exceptional GDP and GMP.
4.Working knowledge of relevant ISO standards and guidance documents
5.Proficient in use of MS Office with ability to complete data analysis using Microsoft excel

SPECIFIC 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.