Manufacturing Technician III - Sterile Injection - 3rd Shift

The Manufacturing Technician III (Compound/Fill/Finish) is accountable for results in a fast-paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The position entails a high level of technical expertise in aseptic processes requiring single-use components, leadership in troubleshooting, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP).

Requirements

• Performs complex manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
• Serves as a subject matter expert (SME) on compounding/filling processes and equipment, providing guidance and training to other manufacturing employees.
• Monitors production processes to ensure adherence to SOPs, batch records, and quality standards, making real-time adjustments to maintain product quality.
• Troubleshoots and resolves complex equipment and process issues, minimizing downtime and ensuring efficient production flow.
• Conducts in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards.
• Collaborates with cross-functional teams (e.g., Manufacturing Specialists, Technical Services, Quality Assurance, Engineering, etc.) on continuous improvement initiatives to enhance product quality, safety, and efficiency.
• Maintains accurate and detailed production documentation.
• Follows applicable SOPs and cGMPs to perform assigned duties and tasks.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Performs in-process sampling, weight checks, and component counting and basic math calculations.
• Performs in-process inspection and finished product visual inspection.
• Performs cleaning of rooms, tools and equipment before and after use.
• Assists with other manufacturing areas as required.
• Other duties as assigned.