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Evergen · 1 month ago

Facilities Technician II

Eden Prairie, MN, Eden Prairie, MN, US

Full-time

Onsite

Mid Level

$22/hr - $25/hr

Evergen is a global industry-leading contract development and manufacturing organization in regenerative medicine. The Facilities Technician II role involves supporting production operations through equipment maintenance and calibration, ensuring compliance with quality standards, and assisting with waste disposal and safety initiatives.

Health CareIndustrial ManufacturingMedical DeviceProduct Design

Responsibilities

Perform and/or facilitate equipment calibrations and preventative maintenance in accordance with internal procedures on process and/or test equipment and facility plant systems within specific timescales / deadlines to keep calibration and maintenance schedule up to date

Perform plant walk-arounds recording the status of plant equipment and associated systems to aid in preventative maintenance. Data gathering on the performance of equipment

Communicate with other departments to assist in the planning of planned or unplanned maintenance which may affect production or quality

Assist with the control and monitoring of production related materials and critical spares

Liaise with external service providers who visit the site to perform critical works, as required

Execute equipment validations, as assigned, on new and existing equipment including IQ/OQ/PQ to ensure that equipment conforms to required specifications. To include introduction of new equipment and systems for production use

Writing/editing documentation such as work instructions, SOP’s etc as applicable

Assist with waste disposal procedures to ensure the safe and compliant disposal of waste from the site

Participate in Health and Safety initiatives throughout the site

Ensure all activities are performed in accordance with cGMP where applicable, ISO 13485 / ISO 22442 and any other relevant regulations or SOPs. Always keep training folder up to date

Actively support timely closure of CAPAs, Non-conformances, and deviation reports wherever the area of expertise allows

Qualification

ISO 13485 experienceCalibrationMaintenanceMedical Device Industry experienceStock control managementValidation of equipmentFault findingSafe manual handlingMicrosoft Office proficiencyTeamworkCommunication skillsOrganizational skillsDetail-orientedSelf-motivated