ENCAPSULATION LEAD OPERATOR

Position Description: SUMMARY:
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.
Key Responsibilities:•\tOversee setup, operation, and cleaning of encapsulation machines in compliance with SOPs and cGMP.
•\tMonitor and adjust equipment to maintain product quality and production efficiency and operate and support multiple machines simultaneously.
•\tLead, train, and coach machine operators; ensure ongoing skill development.
•\tMaintain and track employee training records; conduct periodic evaluations.
•\tComplete and review batch records, logbooks, and production documentation accurately.
•\tMaintain proper documentation practices to support audits and inspections.
•\tEnsure all activities comply with cGMP, SOPs, and regulatory requirements.
•\tPerform basic troubleshooting and assist with minor mechanical maintenance.
•\tEnsure adherence to safety procedures, gowning requirements, and cleanroom standards.
•\tMonitor machine performance and operator productivity; identify areas for improvement.
•\tProvide cross-training and operational support across manufacturing areas as needed.
•\tCoordinate equipment assembly/disassembly and ensure proper machine setup.
•\tMaintain compliance with regulatory requirements and support audit readiness.
•\tProvide operational support in other manufacturing areas as needed.
•\tPerform additional duties as assigned by the Encapsulation Supervisor OR Production Manager.
Educational Qualification & Experience:•\tHigh school diploma or equivalent required.
•\tMinimum 3–5 years of experience in pharmaceutical or related manufacturing industry.
•\tStrong knowledge of cGMP and SOP compliance.
•\tAbility to read, write, and communicate effectively in English.
•\tStrong mathematical and documentation skills.
•\tMechanical aptitude with hands-on experience in encapsulation or similar equipment.