Manufacturing Technician

Key Responsibilities Perform manufacturing procedures within an ISO Class 7 cleanroom in accordance with established SOPs, cGMPs, and safety regulations. Perform aseptic manipulations of cell culture lots and final product assemblies. Handle biological materials while maintaining required storage temperatures and material integrity. Execute manufacturing processes accurately and consistently according to established procedures. Document manufacturing activities in Electronic Batch Records, log sheets, and other controlled documentation. Review completed production records for accuracy, completeness, and cGMP compliance. Enter production and material information into electronic databases and inventory management systems. Perform cleanroom housekeeping and sanitize manufacturing equipment and controlled areas. Record equipment readings and monitor equipment to ensure operation within established specifications. Receive, label, inventory, store, and prepare biological materials and manufacturing supplies. Maintain accurate inventory records, chain of custody, and audit trails. Safely handle biological materials, chemicals, drug products, dry ice, and liquid nitrogen using appropriate PPE and procedures. Follow applicable GMP, GTP, GLP, GDP, ISO, and safety requirements. Work collaboratively with QA, QC, Engineering, Facilities, Materials Management, R&D, Training, and Validation teams. Communicate effectively with cross-functional teams to support manufacturing activities. Maintain a clean, organized, and compliant manufacturing environment. Perform other duties as assigned. Qualifications High school diploma/GED with 2+ years of cGMP experience, or a Bachelor’s degree, preferably in a Life Science or related field. Previous experience in biopharmaceutical, pharmaceutical, cell therapy, biotech manufacturing, or laboratory operations preferred. Experience working in a GMP/cGMP environment preferred. Experience working in an ISO Class 7 cleanroom preferred. Familiarity with aseptic processing and controlled manufacturing environments preferred. Strong attention to detail and ability to perform repetitive tasks accurately. Strong written and verbal communication skills. Ability to follow SOPs, batch records, safety procedures, and regulatory requirements. Basic proficiency with Microsoft Office and Excel. Ability to work independently and effectively within a team environment. Physical & Working Requirements Ability to lift, carry, push, and pull up to 50 lbs. Ability to sit or stand for extended periods. Ability to bend, reach, and perform repetitive hand and finger movements. Ability to gown and gain entry to controlled manufacturing areas. Ability to work with dry ice and liquid nitrogen (LN₂) using appropriate PPE and techniques. Ability to work one weekend day per week and participate in rotating holiday coverage as required. May work in areas containing potentially infectious biological materials and must follow applicable safety procedures and Universal Precautions. #J-18808-Ljbffr