Manufacturing Shift Lead (Aseptic), 1st Shift 6:00am-2:30pm

Job Description

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.

How You'll Contribute

* 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.

What It Takes

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.

What You Bring

* 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 material transaction execution.

* Ability to read, interpret, and execute complex batch records, SOPs, and GMP documentation with strong attention to detail.

* Experience operating automated or semi-automated filling equipment within aseptic manufacturing environments.

* Strong communication,…