Blender Operator I MFG

Job Summary:

The Blender Operator I is responsible for performing pharmaceutical blending and compounding operations involving active pharmaceutical ingredients (APIs), potent compounds, adhesives, solvents, and other hazardous materials in a cGMP-regulated manufacturing environment.

This position supports batch manufacturing activities through proper equipment setup, material dispensing, compounding operations, documentation, cleaning, and in-process monitoring activities. The role ensures manufacturing activities are performed safely, accurately, and in compliance with current Good Manufacturing Practices (cGMP), FDA, DEA, environmental health and safety requirements, and company procedures.

The Blender Operator I is expected to demonstrate operational proficiency, strong documentation practices, teamwork, and consistent execution of manufacturing activities while supporting production schedules, product quality, and inspection readiness.

Job Responsibilities

Manufacturing & Compounding Operations

• Perform pharmaceutical blending and compounding activities in accordance with approved batch records and SOPs.

• Manufacture batches containing active pharmaceutical ingredients (APIs), potent compounds, adhesives, solvents, and other regulated or hazardous materials.

• Assemble, disassemble, operate, clean, and sanitize blending and compounding equipment, kettles, tanks, mixers, pumps, and associated manufacturing systems.

• Perform raw material dispensing, weighing, staging, and verification activities using calibrated equipment and approved procedures.

• Conduct batch record calculations and verify material quantities, yields, and reconciliation activities.

• Perform in-process checks, sampling, and coat weight verification activities as required.

• Monitor and document operational parameters including temperature, mixing speeds, vacuum, pressure, and processing times.

• Support manufacturing operations within production and other departments as needed.

GMP Documentation & Compliance

• Accurately complete batch records, logbooks, equipment usage records, and all GMP documentation in accordance with Good Documentation Practices (GDP).

• Ensure all manufacturing activities comply with FDA, DEA, OSHA, cGMP, and company quality requirements.

• Maintain inspection-ready documentation and work areas at all times.

• Follow data integrity principles and ensure accurate, contemporaneous, and complete documentation practices.

• Comply with all company policies, safety procedures, and standard operating procedures while performing job duties.

• Operates in accordance with the company’s Code of Conduct, Business Ethics, and all established regulatory and compliance requirements.

Equipment & Area Maintenance

• Perform cleaning and line clearance activities for manufacturing equipment and production suites.

• Maintain blending rooms, equipment storage areas, and manufacturing spaces in a clean, organized, and compliant condition.

• Identify and report equipment malfunctions, process abnormalities, or safety concerns promptly.

• Support preventive maintenance and calibration activities as required.

Training & Team Support

• Work collaboratively with Manufacturing, Quality, Warehouse, Engineering, and EHS departments to support operational goals.

• Assist in training and supporting Blender Operator I personnel as directed.

• Participate in operational improvement and safety initiatives.

• Operates in accordance with the company’s Code of Conduct, Business Ethics, and all established regulatory and compliance requirements.

Safety & Environmental Compliance

• Properly use required personal protective equipment (PPE), including respirators, coveralls, gloves, hearing protection, and eye protection.

• Safely handle potent compounds, solvents, and hazardous materials in accordance with established safety procedures.

• Follow all environmental health and safety procedures, including hazardous waste handling and spill response requirements.

• Participate in safety initiatives, risk assessments, and operational improvement activities.

• Perform all other duties as assigned.