Operator Jobs

About The Position

Requirements

• High school diploma or equivalent.
• Successful completion of the National Career Readiness Work Keys assessment.
• Good verbal and written communication skills and ability to train others.
• Ability to perform calculations and conversions involving weights, volumes, and percentages.
• Ability to use basic logic to identify and solve problems, and recognize practical ideas for improving efficiency, effectiveness, and simplicity.
• Demonstrated understanding of systems, equipment, and processes.
• Experience with the Windows operating system.
• Proficient reading, comprehension, and application skills for a diverse set of complicated tasks.
• Ability to wear a respirator if required; no pulmonary restrictions.
• Ability to sustain heavy lifting over extended periods. Listed work-related forces include pulling a pallet of 500 ml bottles on a pallet jack at 28 lb and pushing it at 34.5 lb; a 43 lb header tank lifted by two people; 11 lb cases of 500 ml bottles; and bundles weighing under 20 lb.
• Ability to proceed independently with product processing in accordance with standard methods, SOPs, and Manufacturing Directions using proper aseptic techniques.
• Ability to work in a team environment.

Nice To Haves

• Knowledge of hazardous waste handling.
• Knowledge of decontamination and sterilization.
• Knowledge of traffic patterns.
• Knowledge of or evidence of working with BPE methods.
• Understanding of basic GMP and documentation practices.
• Demonstrated understanding of safe working habits and Material Safety Data Sheets (MSDS).
• Understanding of basic laboratory practices, measurements, biology, and microbiology.
• Understanding of operating in an aseptic environment.
• Knowledge of applicable federal, state, and international regulations, including cGMP, USDA, DOT, EPA, and OSHA.
• Knowledge of corporate guidelines and policies related to the employee’s work.
• Knowledge of drug and chemical names and ability to distinguish similar names and appearances and understand handling precautions.
• Additional education and/or equivalent experience.

Responsibilities

• Prepare, review, and audit assigned records, calibration records, and documentation for completeness and accuracy to maintain regulatory compliance.
• Read and follow schedules, procedures, and documents.
• Assist with training employees in the assigned area and help develop or improve procedures and methods.
• Use computer-assisted data entry and integrated equipment, including MES, SAP, scanners, printers, and scales.
• Assist lower labor grades as needed to complete daily tasks, and perform work of a lower classification when needed.
• Assist the validation group with department equipment validations.
• Start up, operate, monitor, maintain, and help troubleshoot production equipment, including Building B fillers and department lyophilizers.
• Maintain routine instrument calibration schedules as defined by SOPs and perform scheduled preventative maintenance.
• Teach aseptic techniques and monitor others to ensure they are followed in production.
• Evaluate and teach prerequisites for pre-sterile filling, including component sterilization and verification, equipment and room cleaning, room monitoring, HEPA airflow and room pressures, setup, and equipment sterilization.
• Check the availability of items required to maintain schedules, procedures, and documentation.
• Perform housekeeping and safety inspections and issue reports.
• Assist with transfers of new products, test methods, production processes, and technology.
• Aseptically gather and transfer samples for QC testing.
• Interpret process indicators, controls, and PLC controllers in the assigned department.
• Monitor bio-security status and recommend improvements.
• Perform filter integrity testing and prepare accurate documentation.
• Assist a technician under supervision.
• Routinely complete an aseptic qualification program.
• Perform other duties as assigned.

Benefits

• Competitive compensation and benefit programs.
• Support for a healthy working environment, meaningful work, mobility, networking, and work-life balance.