- Aseptic Operations: Operate high-speed sterile filling, sealing, and washing lines (vials, ampoules, or pre-filled syringes) within Grade A/B cleanroom environments.
- Equipment Monitoring: Control and adjust critical process parametersincluding filling volumes, line speeds, and pressure differentialsto ensure optimal machine performance.
- Sterilization Processes: Execute Clean-in-Place (CIP) and Sterilize-in-Place (SIP) protocols for all formulation and filling equipment, including the operation of autoclaves and depyrogenation tunnels.
- cGMP Documentation: Complete Batch Manufacturing Records (BMR), logbooks, and line clearance checklists in real-time compliance with USFDA, MHRA, and WHO-GMP standards.
- Setup & Changeovers: Perform productive machine setups, line clearances, and component changeovers between different product batches to minimize downtime.
- Troubleshooting & Maintenance: Address minor mechanical breakdowns independently and assist the engineering team with preventive maintenance and equipment validation.
- Contamination Control: Strictly adhere to advanced aseptic gowning protocols and cleanroom behavioral guidelines to eliminate any risk of cross-contamination.
- Cross-Functional Teamwork: Coordinate closely with Quality Assurance (QA) for environmental monitoring samples and inline optical inspection protocols.