Senior Aseptic Manufacturing Specialist

Job Description What You'll Do 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. How You'll Contribute 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 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. 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. Powered by Position Details Now Hiring LocationBedford, MA Employment TypeFull-Time Salary Range$32 - $42 Apply Now Share This Career * * * * Ready to Apply? Click the button below to submit your application for this position. Apply Now Other Open Positions Career Aseptic Manufacturing Manager Full-Time•Bedford, MA What You'll Do The Manufacturing Manager, Aseptic Operations leads commercial sterile drug and medical device manufacturing operations across ISO 7 and ISO 5 cleanroom environments,… View Position Career Scientist II, Process Research & Development (R&D) Full-Time•Bedford, MA What You'll Do The Scientist II, Process Research & Development (R&D) supports the development, scale-up, and lifecycle management of drug substance and/or complex materials (e.g.,… View Position Career Shift Lead (Crosslink) - Weekend Shift: Sat/Sun/Mon Full-Time•Bedford, MA What You'll Do The Shift Lead oversees day-to-day manufacturing floor operations within a regulated cGMP environment, ensuring safety, quality, and production requirements are met across… View Position Products Navigation" data-detect-dark-bg="true">Products Regenerative Solutions OA Pain Management Our Technology Resources Navigation" data-detect-dark-bg="true">Resources Literature & Videos News & Blog Just For Patients Events Certifications Form 1095-C Instructions for Use Find a Doctor Company Navigation" data-detect-dark-bg="true">Company About Anika Meet Our Team Our Story Join Us Connect Navigation" data-detect-dark-bg="true">Connect Investor Relations Contact Us Find a Rep Follow Us LinkedIn Instagram Facebook X YouTube 3 Media Web Solutions, Inc 2026 Anika Therapeutics, Inc. All rights reserved. Privacy Policy Terms of Use Legal