ENCAPSULATION OPERATOR in SOMERSET, New Jersey at ASPIRE PHARMACEUTICALS INC

The Encapsulation Operator is responsible for the setup, operation, cleaning, and monitoring of encapsulation machines in compliance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and company safety policies. This role ensures accurate and efficient production while maintaining product quality, proper documentation, and equipment performance in a pharmaceutical or nutraceutical manufacturing environment.

• Operate, set up, clean, and assemble encapsulation machines according to SOPs and cGMP requirements.

• Monitor machine operation and make adjustments to maintain product quality and production efficiency.

• Perform equipment checks before, during, and after production runs.

• Complete batch records, logbooks, and production documentation accurately and in a timely manner.

• Follow all cGMP, SOP, safety, and gowning requirements during manufacturing operations.

• Inspect capsules for quality attributes including appearance, weight variation, defects, and fill consistency.

• Assist in troubleshooting machine issues and report mechanical concerns to maintenance or supervisors.

• Support machine changeovers, line clearance activities, and cleaning verification processes.

• Maintain cleanliness and organization of equipment and manufacturing areas.

• Ensure proper handling and identification of materials, components, and finished products.

• Assist with inventory reconciliation and material accountability during production activities.

• Work collaboratively with Quality Assurance, Maintenance, Warehouse, and Production teams.

• Support audit readiness and regulatory compliance activities.

• Cross-train and provide operational support in other manufacturing areas as needed.

• Perform additional duties as assigned by the Encapsulation Lead, Supervisor, or Production Manager.

• High school diploma or equivalent required.

• Minimum 1–3 years of manufacturing experience in pharmaceutical, nutraceutical, food, or related industry preferred.

• Knowledge of cGMP and SOP compliance preferred.

• Basic mechanical aptitude and ability to operate manufacturing equipment.

• Ability to read, write, and communicate effectively in English.

• Good mathematical, organizational, and documentation skills.

• Ability to stand for 8-10 hours during shifts.

• Ability to lift up to 50 lbs occasionally.

• Ability to bend, reach, push, pull, and perform repetitive tasks as required.

• Constant exposure to noise levels loud enough to require hearing protection.

• Exposure to warm temperature conditions, machine vibration, fumes, and oily/wet environments is sufficient to cause minor discomfort.

• Employees are required to wear appropriate Personal Protective Equipment (PPE), including protective eyewear, hair nets, uniforms, safety shoes, gloves, and hearing protection as required.

• The incumbent must be able to perform this job safely in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and company safety policies without endangering the health or safety of self or others.