Blender Operator I

Job Responsibilities

• 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.

Qualifications

• High school diploma or General Education Degree (GED) required.
• Technical certification or vocational training in manufacturing, pharmaceutical operations, or related discipline preferred.
• Minimum of 5 years of experience in pharmaceutical, chemical, food, or other regulated manufacturing environments required.
• Minimum of 3 years of experience as a Blender Operator I or equivalent pharmaceutical manufacturing experience preferred.
• Experience handling potent compounds or hazardous materials preferred.
• Demonstrated experience operating blending, mixing, coating, or compounding equipment preferred.
• Strong knowledge of cGMP requirements, GDP practices, SOP compliance, and pharmaceutical manufacturing operations.
• Understanding of FDA, DEA, OSHA, and hazardous material handling requirements.
• Ability to read, understand, and execute batch records, SOPs, cleaning procedures, and safety documentation in English.
• Ability to accurately complete GMP documentation and perform batch accountability calculations.
• Strong mathematical skills including percentages, ratios, decimals, and yield calculations.
• Mechanical aptitude and ability to assemble/disassemble manufacturing equipment.
• Strong attention to detail and ability to identify process deviations or abnormalities.
• Ability to work independently with minimal supervision while maintaining a high level of accuracy and compliance.
• Effective communication and teamwork skills.
• Basic computer literacy and familiarity with electronic manufacturing systems preferred.

Physical Requirements and Working Conditions

• Ability to stand, walk, bend, reach, climb, and perform repetitive movements throughout the shift.
• Ability to frequently lift, push, pull, and move materials or equipment up to 50 pounds.
• Regular exposure to manufacturing equipment, moving mechanical parts, solvents, airborne particles, potent compounds, and cleaning chemicals.
• Required use of personal protective equipment (PPE), including respirators, full-body coveralls, gloves, hearing protection, and eye protection.
• Ability to work in classified manufacturing environments with varying temperatures, humidity, and noise levels.
• Ability to work overtime, weekends, holidays, or alternate shifts as operationally required.