Shift Lead Aseptic Manufacturing

What You’ll Do

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.

This role requires strong technical expertise and leadership within a highly regulated aseptic manufacturing environment. The position serves as the primary on‑floor operational leader during assigned shifts and is responsible for maintaining compliance, production continuity, contamination control, and manufacturing performance. The role requires sound decision‑making, attention to detail, strong communication skills, and the ability to effectively coordinate personnel, equipment, materials, and production priorities in a fast‑paced manufacturing setting.

• 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…