Role Summary
Cell Lab Technician responsible for set-up, operation, and troubleshooting of production equipment in the production areas. Will document work and perform computer-related tasks, integrating LEAN into daily practices. Responsible for safely producing vaccines that meet product specifications in accordance with current Good Manufacturing Practice standards.
Responsibilities
- Perform duties associated with aseptic processes, weighing, measuring, counting, calculations, sampling, and verifications required for biological production processes in accordance with batch production records (BPR) and in compliance with current good manufacturing practice (cGMP) standards, all current safety standards and site procedures.
- Understand, perform and teach others basic operation of production equipment and ensure all equipment, instruments and production materials are released and available for use. Look up and perform transactions within the electronic inventory management system.
- Oversee production processes, cleaning, environmental monitoring and personnel and perform in-process batch quality checks per the written procedures. Follow safety rules, wear appropriate safety equipment and maintain proper safety practices at all times.
- Basic computer skills to create and update standard operating procedures and write deviation reports, and to complete all training as assigned to include general company procedures, area procedures, equipment operation, computer operation, safety, GMP and other as needed.
- Generate or collect new ideas about workplace and processes.
Qualifications
- Required: High School Diploma/GED plus 4 years relevant experience
- Required: Basic computer skills with Word, Excel and Electronic Management Systems
- Required: Ability to read, interpret and conform to batch records, Quality and Safety requirements
- Required: Knowledge of manufacturing function and general understanding of production process to apply to typical situations
- Preferred: Basic biological equipment knowledge and/or experience (e.g., cell growth, centrifuge, concentration) and basic understanding of biological organisms
Additional Requirements
- Overtime, weekend, and holiday work may be required