Senior Aseptic Manufacturing Specialist

What You’ll Do

• 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.

What It Takes

• Advanced technical knowledge and hands-on leadership within highly regulated aseptic manufacturing environments.
• Supports the reliable execution of sterile manufacturing processes while ensuring compliance, contamination control, product quality, and schedule adherence.
• Strong technical judgment, attention to detail, and the ability to make sound real-time decisions in fast-paced cleanroom operations.
• Strong communication skills, operational discipline, troubleshooting capability, and the ability to train and influence others in support of safe and compliant manufacturing practices.

What You Bring

• 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.

Nice to Have

• 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.