Position Summary

This position has the responsibility to ensure the proper operation and maintenance of all facility systems and equipment. They will take corrective action and repair equipment when necessary. Provides appropriate notification and documentation of all work performed. Daily activities may include performing mechanical and/or electrical troubleshooting and tasks, PM activities, and other tasks involving various operations and repairs within a cGMP manufacturing facility. This position is known internally as Senior Facilities Operator.

Essential Functions (ES) and Responsibilities

Responds to emergencies as requested utilizing resources to effectively repair and ensure the safety and availability of ADMA systems and equipment.

On non-supervised shifts, the individual is responsible for the continued operations of the facility, plant, and production systems. This employee has the authorization in the absence of written procedures or instructions to start and stop equipment to ensure continued operation until necessary corrective action can be taken and if necessary, call in additional off-duty personnel to assist in problem resolution.

Responsible for the proper operation and maintenance of all facility systems. This includes, but is not limited to the following: routine preventative maintenance; corrective maintenance and document related work performed, materials, parts and supplies used in work order documentation for systems like Water for Injection (WFI) systems, autoclaves, HVAC systems, steam systems, high capacity chillers, ultra-low temperature refrigeration systems, cooling towers, liquid pumping and compressible gas fluid systems including air compressors, nitrogen, natural gas, diesel fired boilers, clean steam, waste water systems etc.

Performs the job function in compliance with safety, health, environmental, and governmental regulations and in compliance with ADMA SOPs for facility operations.

Research codes and existing ADMA procedures for conformance to regulatory codes.

Insure outside venders and contractors are trained in applicable ADMA procedures regarding safety, environmental, and health. They must also be monitored to comply with all ordinances such as electrical and construction codes.

Assist the Instrumentation Technician II in the calibration and repair of devices within the manufacturing facility.

Assist facility management in the training and the development of skills for Facility Operations I & II.

Ensure plant is clean and free of debris or clutter.

Will assist in special projects and/or construction projects. Duties may include demolition, renovation, and new construction.

Job Responsibilities or Job Requirements

Competencies

Experience Requirements

Education Requirements: High school diploma or equivalent plus four (4) years of technical or vocational training.  Equivalent experience may be substituted for technical/vocational experience.

Experience Requirements: Six years + previous maintenance in a manufacturing environment and/or construction experience. cGMPs and ISO regulatory knowledge needed for this position.

Preferred Experience

Preferred Education Requirements: Florida Professional License preferred.       

Preferred Experience: Six years’ experience in the pharmaceutical/medical devices industry preferred.

Compliance Requirements (ES)

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.