Equipment Operator

Job Description

POSITION SUMMARY

The Equipment Operator is responsible for the safe and efficient operation of production equipment in a current Good Manufacturing Practices (cGMP) regulated manufacturing environment. This role plays a critical part in ensuring product quality, regulatory compliance, and consistent production output. The Equipment Operator works closely with the Lead Equipment Operator, production, and quality teams to uphold Eosera’s standards for safety, documentation, and continuous improvement.

KEY RESPONSIBILITIES

Equipment Operation Set up, operate, and monitor production machinery in accordance with equipment instructions (WI). Perform line changeovers and equipment adjustments between production runs to ensure proper configuration for each batch. Conduct start-up, shutdown, and cleaning of assigned equipment. Monitor equipment performance during production runs and elevate issues to maintenance or supervisors as needed. Documentation & Recordkeeping Adhere strictly to current Good Manufacturing Practices (cGMP) regulations and Eosera’s Quality Management System (QMS) at all times. Follow all applicable SOPs, work instructions, and batch record requirements for each production activity. Perform and document in-process quality checks including weight verification, fill volume, seal integrity, and label accuracy. Immediately report any product, equipment, or process deviations to the quality or production team. Ensure all materials used in production are properly identified, labeled, and within expiration or retest dates. Assist in compounding when necessary. Accurately complete batch records, production logs, equipment logs, sanitation log and all required documentation in real time. Ensure all entries are legible, complete, and comply with data integrity standards (no blank fields, no overwriting without proper correction). Safety, Sanitation & Housekeeping Maintain a clean, organized, and sanitary workstation and production area at all times. Follow all environmental health and safety (EHS) policies and wear required personal protective equipment (PPE). Perform cleaning and sanitation of equipment and work areas per approved cleaning procedures. Report any safety hazards, near-misses, or injuries to supervisors immediately. Teamwork & Continuous Improvement Work collaboratively with production, quality, and warehouse teams to meet daily production goals. Actively identify opportunities to improve efficiency, reduce waste, and enhance product quality—and share ideas with the team. Support cross-training efforts and assist teammates with manufacturing, inventory, or warehouse tasks as needed. Participate in team meetings, training sessions, and continuous improvement initiatives.

QUALIFICATIONS

Required High school diploma or equivalent. Minimum 1 year of experience operating production machinery in a manufacturing environment. Demonstrated knowledge of or ability to learn cGMP, GMP, or regulated manufacturing requirements. Strong attention to detail with a commitment to accuracy in documentation and production tasks. Ability to read, understand, and follow SOPs, work instructions, and batch records. Ability to stand for extended periods, lift up to 40 lbs, and perform repetitive tasks. Reliable, punctual, and able to work effectively both independently and as part of a team. Preferred Experience in a pharmaceutical, nutraceutical, medical device, or FDA-regulated manufacturing environment. Familiarity with filling, labeling, packaging, or assembly equipment. Knowledge of data integrity principles and good documentation practices (GDP). Experience with lean manufacturing or continuous improvement m #J-18808-Ljbffr Eosera, Inc.