Sterile Area Operator - LG

Overview

Join to apply for the Sterile Area Operator - LG 9-11 role at Endo
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We are seeking capable individuals to support aseptic and non-aseptic GMP areas with cleaning, sanitation, and operational responsibilities in the Sterile Filling Department. This role supports a production workflow and requires adherence to safety, quality, and regulatory standards.

In accordance with written or oral instruction, cleans sterile and non-sterile areas. Operates auto scrubber, floor buffing machines, and carpet extractors. Mixes chemicals and operates fogging equipment.

• Operate all equipment in the department for cleaning, disinfecting/sanitizing/fogging aseptic and non-aseptic GMP areas
• Maintain supplies and work area in a clean and orderly fashion
• Receive supplies and move to designated storage area
• Check equipment and work area; notify supervisor when repairs are needed
• Collect and stock sterile and non-sterile garb; manage garb areas
• Maintain respirators, clean after use and store properly
• Dispose of trash and waste properly
• Flush, clean, and document safety showers and eye washes; report malfunctions
• Prepare sanitation solutions used to clean aseptic and non-aseptic areas
• Clean and properly store cleaning equipment

• Operate washers, cappers and other equipment within the Sterile Filling Department
• Packing into trays/cases; may require lifting up to 35 lbs
• Evaluate finished product as required
• Maintain smooth production flow and monitor equipment
• Elevate any equipment or process deviations
• Perform other duties as assigned by supervision
• Maintain supplies and work area in a clean and orderly fashion
• Maintain supplies in controlled areas
• Check equipment and notify supervisor if repairs are needed
• Clean and properly store waste containers for sterile filling production waste

• Document GMP records, LUMAC logbooks and sanitation schedules upon completion of daily work; update room status
• Proactively communicate with area supervisor to correct documentation deficiencies

• Perform all functions in compliance with SOPs, GMPs and corporate regulations
• Observe safety and health regulations

• Operate equipment or perform duties within the LG9-LG11 upgrader path; rotate assignments for ergonomic safety
• Assist in training new colleagues and maintain training requirements
• Maintain eligibility to be Aseptic Core qualified and Media qualification

Education & Experience

• High School Diploma, GED or equivalent
• Successful completion of certified in-house qualification programs
• Willingness to continue ongoing training as required
• Must be aseptically area qualified and maintain qualifications

• Basic understanding of manufacturing or packaging operations
• Basic knowledge of industry practices and standards; able to apply basic principles
• Able to understand and comply with current standards and regulations (cGMP, OSHA, EEOC, EPA, FDA, DEA)

• Able to prioritize work and multi-task
• Quality-focused; seeks to improve and ensure accuracy
• Demonstrates productivity and timely task completion
• Strong safety and security awareness
• Adaptable to changes and able to manage competing demands
• Consistent attendance and reliability
• Dependable and capable of following instructions and meeting commitments

• Frequent handling and use of hands; ability to lift up to 50 pounds occasionally
• Specific vision abilities required
• Exposure to moving mechanical parts and to chemicals
• Work in a production/manufacturing environment with ISO-controlled areas as needed

We firmly believe in equal employment opportunity and strive to create an atmosphere where all employees feel valued, respected, and empowered. Employment decisions are based on qualifications, skills, and merit.

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Management and Manufacturing
• Industries: Pharmaceutical Manufacturing