Lab Technician (Entry, Lewisville)

Steri-Tek is dedicated to providing a high-quality sterilization service and superior customer service to the industries it serves.

Lab Technician will be responsible for providing customer support and executing dose mapping and possibly assist in validation projects. They will be expected to answer technical questions in a timely and professional manner, ensure that customer products are processed per specification, and maintain accurate records. The technician will also be responsible for executing dose map projects, writing reports, and ensuring equipment calibration.

Successful completion of this position includes complete and proper execution of the Steri-

Tek Standard Operating Procedure (SOP) Manual.

Responsibilities

Customer Support

• Answer customer questions regarding validations, dose mapping, packaging, product materials, and any other technical questions in a timely and professional manner.

• Be familiar with ISO 11137 standards (11137-1, 11137-2, 11137-3), and how e-beam irradiation affects different materials.

• Inform customers of optimal packing and box configurations, how density of product affects dosing, and how temperature can impact a product.

Radiation Services Projects

• Maintain a basic level of knowledge of Quality System Requirements (ISO13485, 21 CFR 820).

• Ensure customer products are prepared and processed per specification following the applicable SOP’s.

• Write protocols for dose studies, perform the dose studies, and write reports for the dose studies.

• Measure dosimeters and be proficient with spectrophotometers.

• Assist with equipment calibration and report writing.

• Assist in dosimeter calibration.

• Assist in extra Radiation Services tasks.

• Ensure incoming products have been received and prepared for applicable processing needs.

• Contact customers as required to resolve any discrepancies with incoming product.

• Ensure documentation and reporting for projects are accurately completed and on time.

Validations Projects

• Assist with dose audit projects.

• Assist with validations projects.

• Assist with verification dose projects.

Goals and additional responsibilities

• Maintain comprehensive records of servicing and maintenance for equipment.

• Train to Quality inspections and support as necessary directed by the Quality Manager.

• Provide support to complete dose mapping projects as necessary and directed by the Radiation Services Supervisor.

• Provide recommendations for process improvement and system health.

• Provide technical expertise to other departments on an as-need basis (e.g. provide technical background to Quality for non-conformance, CAPA process. Provide technical background to Radiation Services for validation activities).

• Maintain training to provide support for PQ dose mapping to the Radiation Services department.

Other duties as assigned by Supervisor/Manager.

The Lab Technician is an entry-level position responsible for supporting the daily operations of the Radiation department. The Lab Technician will execute radiation processing tasks including dose mapping, dose measurements/placement, sterilization validation work, and protocol/report creation. Ensures accuracy in data collection and product handling for sterilization validation and production support.