Operator I, Production

• Perform aseptic processing tasks, including cleaning cGMP Areas, Parts Preparation Filter Integrity Testing sterilization, operating parts washers and autoclaves, perform tray loading and unloading, per wok instructions, standard operating procedures. Perform general material handling.
• Set up, calibrate, and operate aseptic processing equipment such as isolators, filling machines, and autoclaves.
• Monitor system performance during production runs and ensure all parameters (e.g., temperature, pressure, flow rates) meet established criteria.
• Work with QA, QC, and Maintenance teams to troubleshoot issues, resolve deviations, and report equipment malfunctions as needed.
• Complete applicable logbook, form, and batch record documentation as required while adhering to strict cGMP and Good Documentation Practices.
• Complete required checklists and forms for each production batch and ensure all documentation is properly filed and stored.
• Maintain aseptic and PPE qualifications to work safely in Grade A/B cleanrooms, following all gowning, safety, and sterile handling protocols.
• Ensure compliance with all applicable policies, regulatory requirements, and current Good Manufacturing Practices (cGMPs), including proper handling of hazardous materials and strict adherence to established Quality System standards throughout the production process.
• Work collaboratively with other operators, supervisors, and departments to ensure smooth production processes and maintain effective communication across teams.
• Participate in continuous improvement efforts and suggest improvements to enhance efficiency and quality in the production process.
• Other duties as required and assigned by management.

• High school diploma or equivalent; additional technical or vocational education is a plus.
• Minimum 1 year experience working in the pharmaceutical/biopharma/biotech industry and within aseptic clean room environments.
• Strong mechanical aptitude and problem-solving skills.
• Experience with automated production equipment, particularly sterile filling and packaging systems, is a significant advantage.
• Knowledge of GMP, FDA regulations, and other industry-specific standards (ISO, etc.).
• Ability to read and understand SOPs, work instructions, and technical documentation.
• Ability to understand equipment alarms and escalate as necessary.
• Exceptional attention to detail, accuracy, and documentation skills.
• Ability to work in a cleanroom environment with strict sterility requirements.
• Good communication skills and the ability to work collaboratively in a team-oriented environment.
• Flexibility to work in shifts, including evenings, nights, weekends, and holidays, as required by production schedules.
• Ability to wear appropriate personal protective equipment (PPE) such as gloves, goggles, and respirators.
• Meet minimal visual acuity requirements necessary for quality assessments in a production or packaging environment.
• Be able to be medically cleared to wear full-face tight-fitting respirator based on OSHA Respiratory Protection Standard.
• Perform other duties, as required and assigned by management.

• Ability to stand for long periods and lift up to 50 lbs as required.
• Ability to work in a cleanroom environment requires wearing PPE, including gloves, gowns, face masks, and hairnets.
• Ability to operate and maintain complex equipment.
• Cleanroom environment, with controlled temperature and humidity.
• May be required to work extended hours, weekends, or shift rotations to meet production demands.
• Exposure to sterile materials and handling of chemicals (as per safety protocols).

Ferring