Blender Operator I

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.

Job Requirements

Education

· High school diploma or General Education Degree (GED) required.

· Technical certification or vocational training in manufacturing, pharmaceutical operations, or related discipline preferred.

Experience

· 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.

 

 

 

 

 

Knowledge, Skills and Abilities

· 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 include 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.

 

 

 

 

 

 

 

 

 

 

Medical Surveillance / Respiratory Protection Requirement

As a condition of employment, employees assigned to this position may be required to wear respiratory protection equipment while performing manufacturing, cleaning, dispensing, or material handling activities involving potent compounds, pharmaceutical powders, airborne particulates, solvents, or other hazardous materials.

In accordance with OSHA Respiratory Protection Standard 29 CFR 1910.134, employees required to wear respirators must complete a medical evaluation questionnaire consistent with Appendix C of the standard and be medically cleared to wear a respirator prior to performing applicable job duties. Additional evaluations may be required as determined by Environmental Health & Safety (EHS), Occupational Health, or regulatory requirements.

Employees must also comply with all applicable respiratory protection, PPE, safety training, and fit-testing requirements established by the company and regulatory agencies.

• Education

• High school diploma or general education degree (GED)

 

• Experience

• Minimum of 1 year of related experience and/or training in Manufacturing/Packaging (pharmaceutical manufacturing, food manufacturing) in a GMP environment required; or equivalent combination of education and experience.