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.