FILL AND GEL PREP OPERATOR

Job Description

Job Description

Position Description: Position Summary:
The Fill & Gel Prep Operator is responsible for preparing gel and fill materials, operating blending and mixing machinery, and ensuring accurate documentation of all batch-related activities. This role supports softgel manufacturing operations by ensuring all materials are prepared, blended, and transferred in compliance with approved Batch Manufacturing Records (BMRs), Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and safety requirements.
Essential Duties and Responsibilities:•\tOperate blending and mixing machinery independently and as part of a team to prepare gel mass and fill formulations.
•\tPrepare, weigh, and verify raw materials accurately according to approved BMRs and manufacturing instructions.
•\tPerform gel preparation and fill material processing including mixing, blending, heating, and transfer operations.
•\tMaintain constant attention to manufacturing parameters and batch record documentation throughout production activities.
•\tAccurately complete all batch manufacturing records, blending logs, and related documentation in compliance with SOPs and GDP requirements.
•\tVerify labels, materials, and components against batch manufacturing records to ensure accuracy and compliance.
•\tMonitor equipment and product conditions and immediately report any abnormal conditions, deviations, or safety concerns to management.
•\tPerform equipment setup, cleaning, and changeover activities in accordance with SOPs and cGMP requirements.
•\tHandle materials and containers safely, including lifting up to 50 lbs and pushing/pulling containers up to 500 lbs with appropriate equipment.
•\tMaintain clean, organized, and inspection-ready production areas with proper status labeling of equipment and materials.
•\tEnsure compliance with all safety procedures, SOPs, and cGMP guidelines to protect self and others in the workplace.
•\tSupport team operations and collaborate with other departments including Quality Assurance, Encapsulation, Maintenance, and Warehouse.
•\tPerform other duties as assigned by Supervisor / Manager.
Educational Qualifications and Experience:•\tHigh School Diploma or equivalent required.
•\t1–3 years of experience in the pharmaceutical or related manufacturing industry.
•\tStrong knowledge of cGMP standards and Good Documentation Practices (GDP).
•\tAbility to read, write, and speak English fluently.
•\tExcellent writing, communication, and mathematical skills required.
•\tExperience in blending, mixing, or softgel manufacturing processes preferred.
Physical Requirements:•\tAbility to stand and walk for extended periods during the shift.
•\tFrequent handling of materials, including lifting up to 50 lbs.
•\tAbility to push/pull heavy containers up to 500 lbs using appropriate equipment.
•\tWork in environments involving heat, mixing equipment, and manufacturing machinery.
Work Environment:•\tSoftgel pharmaceutical and nutraceutical manufacturing environment.
•\tExposure to blending, mixing, and heated processing equipment.
•\tRequired use of Personal Protective Equipment (PPE).
•\tOvertime and weekend work may be required based on production needs.