ENCAPSULATION LEAD OPERATOR in SOMERSET, New Jersey at ASPIRE PHARMACEUTICALS INC

The Encapsulation Lead Operator is responsible for overseeing the setup, operation, and performance of encapsulation machines while ensuring compliance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP). This role leads and trains machine operators, ensures production efficiency, maintains product quality, and supports troubleshooting and minor mechanical adjustments. The Lead Operator plays a critical role in maintaining safety, quality, and productivity across the encapsulation production line.

• Oversee setup, operation, and cleaning of encapsulation machines in compliance with SOPs and cGMP.

• Monitor and adjust equipment to maintain product quality and production efficiency and operate and support multiple machines simultaneously.

• Lead, train, and coach machine operators; ensure ongoing skill development.

• Maintain and track employee training records; conduct periodic evaluations.

• Complete and review batch records, logbooks, and production documentation accurately.

• Maintain proper documentation practices to support audits and inspections.

• Ensure all activities comply with cGMP, SOPs, and regulatory requirements.

• Perform basic troubleshooting and assist with minor mechanical maintenance.

• Ensure adherence to safety procedures, gowning requirements, and cleanroom standards.

• Monitor machine performance and operator productivity; identify areas for improvement.

• Provide cross-training and operational support across manufacturing areas as needed.

• Coordinate equipment assembly/disassembly and ensure proper machine setup.

• Maintain compliance with regulatory requirements and support audit readiness.

• Provide operational support in other manufacturing areas as needed.

• Perform additional duties as assigned by the Encapsulation Supervisor OR Production Manager.

• High school diploma or equivalent required.

• Minimum 3–5 years of experience in pharmaceutical or related manufacturing industry.

• Strong knowledge of cGMP and SOP compliance.

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

• Strong mathematical and documentation skills.

• Mechanical aptitude with hands-on experience in encapsulation or similar equipment.