Senior Aseptic Manufacturing Specialist

Senior Aseptic Manufacturing Specialist

The Senior Aseptic Manufacturing Specialist provides advanced technical support, process expertise, and on the floor leadership for sterile manufacturing operations within ISO 7 and ISO 5 cleanroom environments, ensuring compliant, reliable, and efficient execution of aseptic manufacturing processes. In this role, you serve as a subject matter expert in aseptic technique, contamination control, sterile processing, and batch execution.

Executes and supports critical aseptic manufacturing operations including equipment setup and sterilization, dissolution, bulk preparation, sterile filtration, aseptic tank-to-tank transfers, and aseptic filling activities.

Provides on the floor technical leadership and real-time troubleshooting support for aseptic operations and manufacturing equipment issues.

Ensures adherence to FDA cGMPs, ISO 13408, EU GMP Annex 1, and internal procedures governing sterile manufacturing and contamination control practices.

Performs in-process checks and monitors critical process parameters to ensure compliance with batch record requirements and operational standards.

Conducts detailed batch record reviews for accuracy, completeness, and compliance to support timely batch release and closure activities.

Supports SAP/ERP transactions related to material consumption, inventory management, work orders, and material status tracking.

Provides hands-on training, coaching, and qualification support for operators in aseptic technique, cleanroom behavior, equipment operation, and batch execution practices.

Supports investigations, deviations, nonconformances (NCRs), and CAPAs by providing technical input, participating in root cause analysis activities, and implementing corrective actions.

Ensures disciplined execution of contamination control practices, gowning procedures, and ISO 5 open operation standards.

Supports environmental monitoring response activities, including containment actions, documentation, and escalation of potential risks.

Collaborates cross-functionally with Quality Assurance, Engineering, Validation, and Manufacturing leadership to resolve operational issues and improve process reliability.

Maintains clear communication with manufacturing leadership regarding equipment status, operational risks, and production readiness.

Performs other duties and projects as assigned.

This role requires advanced technical knowledge and hands on leadership within highly regulated aseptic manufacturing environments. The Senior Aseptic Manufacturing Specialist is responsible for supporting the reliable execution of sterile manufacturing processes while ensuring compliance, contamination control, product quality, and schedule adherence. The position requires strong technical judgment, attention to detail, and the ability to make sound real time decisions in fast paced cleanroom operations. Success in this role depends on strong communication skills, operational discipline, troubleshooting capability, and the ability to train and influence others in support of safe and compliant manufacturing practices.

Bachelor's degree in Life Sciences, Engineering, or a related discipline; equivalent experience may be considered.

Minimum of 5 years of experience in cGMP sterile manufacturing or aseptic processing environments.

Demonstrated expertise in aseptic technique, sterile filtration, and ISO 5 open operations.

Strong understanding of cGMP requirements, ISO 13408, and EU GMP Annex 1 regulations.

Experience executing and reviewing batch documentation within regulated manufacturing operations.

Ability to troubleshoot manufacturing equipment issues and appropriately escalate operational concerns.

Strong verbal and written communication skills with the ability to train, mentor, and support manufacturing personnel.

Ability to work independently, prioritize tasks, and make effective decisions in real-time production environments.

Experience supporting deviations, NCRs, CAPAs, and quality system investigations.

Familiarity with production scheduling, resource planning, or shift coordination activities.

Experience using equipment work request systems and maintenance workflow processes.

Strong attention to detail and documentation accuracy within GMP manufacturing environments.

Experience with SAP or similar ERP systems supporting manufacturing operations and inventory transactions.

Demonstrated commitment to aseptic discipline, contamination control, safety, and continuous improvement initiatives.