Shift Lead Aseptic Manufacturing

Job Title

Shift Lead Aseptic Manufacturing

The Shift Lead Aseptic Manufacturing leads day-to-day aseptic manufacturing floor operations for sterile drug and medical device products produced within ISO 5 and ISO 7 cleanroom environments, ensuring safe, compliant, and efficient execution of manufacturing activities. In this role, you serve as a subject matter expert in aseptic processing, contamination control, cleanroom operations, and on-floor manufacturing execution while providing direct leadership and technical guidance during assigned shifts.

• Lead and coordinate daily aseptic manufacturing activities, including dissolution, formulation, sterile filtration, filling, sterilization, and supporting cleanroom operations.
• Serve as the primary on-floor technical lead responsible for troubleshooting, issue resolution, escalation, and maintaining uninterrupted manufacturing operations.
• Execute and oversee critical aseptic operations to ensure product quality, batch integrity, and compliance with aseptic processing standards.
• Coordinate manufacturing activities with Supervisors and cross-functional partners to support production schedules and customer delivery commitments.
• Perform formulation calculations, sampling, adjustments, and material preparations based on QC test results while identifying and mitigating operational risks.
• Conduct and oversee environmental monitoring activities, including viable air sampling, surface sampling, and personnel monitoring within aseptic manufacturing areas.
• Communicate staffing plans, assign daily work activities, manage shift coverage, and resolve real-time production and operational issues.
• Lead shift meetings, manufacturing direction indicator (MDI) discussions, and end-of-shift handoffs to communicate priorities, metrics, risks, and operational status.
• Ensure strict adherence to FDA cGMP, ISO, OSHA, EPA, and company quality requirements across all manufacturing activities.
• Review and verify batch records, logbooks, forms, and GMP documentation for accuracy, completeness, and compliance prior to Quality submission.
• Initiate and support deviations, investigations, environmental monitoring excursions, CAPAs, and corrective actions in collaboration with cross-functional teams.
• Monitor floor inventory, material readiness, and material consumption activities to support uninterrupted manufacturing operations.
• Execute ERP/MRP transactions, including material issuance, consumption, returns, receipts, and process order confirmations.
• Create and manage BMRAM work orders to support production execution, equipment readiness, and changeover activities.
• Support commissioning, qualification, validation, media fills, and implementation of process improvements within manufacturing operations.
• Recommend and implement process, ergonomic, safety, and operational improvements to support continuous improvement initiatives.
• Train, mentor, and develop manufacturing personnel on aseptic technique, gowning qualification, environmental monitoring, equipment operation, and GMP expectations.
• Provide manufacturing performance metrics and operational updates to leadership, including schedule adherence, yields, fill volumes, and environmental monitoring trends.
• Perform other duties and projects as assigned.

• Bachelor's degree in Engineering, Chemistry, Manufacturing, or a related technical discipline preferred; equivalent relevant experience may be considered.
• Minimum of 6 years of experience in cGMP-regulated pharmaceutical or medical device manufacturing environments.
• Minimum of 2 years of experience in a lead or floor leadership role with demonstrated ability to train, mentor, and guide manufacturing personnel.
• Demonstrated experience with aseptic processing operations, including ISO 5 and ISO 7 cleanroom environments, aseptic manipulations, product transfers, and syringe filling operations.
• Strong understanding of cGMP requirements, aseptic behavior, contamination control, and cleanroom operations.
• Experience with Material Requirements Planning (MRP) systems, including production planning and…