Princeton, NJ 08540
- Operate and monitor the filling operations using cGMP and company’s SOP’s. Provide technical support and troubleshooting expertise to ensure sterile injectable products are manufactured in accordance with Standard Operating Procedures, current Good Manufacturing Practices and Safety Policies
- Operate and monitor filling equipment utilizing HMI’s, isolator technology, parts washer, autoclave, vial washers, depyrogenation tunnels etc…
- Perform trending and monitoring of critical quality attributes, critical process parameters to maintain product quality.
- Offer technical support in root cause failure analysis for production, EHS, and Quality Incidents.
- Coordinate the equipment readiness within manufacturing.
- Participate in production planning and scheduling.
- Identify opportunities and effectively evaluate initiatives of process optimization, cost reduction, and quality improvement.
- Develop equipment and process standards, operating procedures, and training materials.
- Be on-call and respond to any after-hour event that impacts production.
- Actively participate in technology transfer.
- Support Pilot Test Runs, Validation Runs, Engineering Runs, and any other requirements as needed.
- Perform cleaning and sanitization of equipment and facility as necessary.
- Complete other duties and tasks as assigned.
- Input into and review production logbooks as required.
- Maintains safe and clean work environment by following current good manufacturing practices (cGMP), and standard operating procedures; complying with legal regulations; monitoring environment.
- Keeps equipment operating by following operating instructions; troubleshooting breakdowns; calling for repairs.
- Documents production by completing forms, reports, logs, and records of equipment and batch records to a cGMP and GDP standard.
- Perform inspection, cleaning, and maintenance of the equipment in accordance with operational instructions.
- Strictly follow the internal SOPs and external regulations.
- Strictly following health and safety procedures and protocols.
- Quick and effective diagnosis and troubleshooting of routine or minor problems
- Bachelor degree in mechanical engineering is preferred
- Fluent in Chinese is preferred given close communication with vendors in China is needed
- 3+ Commercial pharmaceutical manufacturing experience is preferred.
- Demonstrate in-depth understanding of technical equipment used in pharmaceutical manufacturing.
- Flexible work hours and schedules.
- Attention to details and a strong focus on quality and safety.
- Thorough knowledge of machinery processes in an aseptic manufacturing environment.
- Thorough understanding of Standard Operating Procedures and current Good Manufacturing Practices.
- Knowledge of accepted practices and regulatory requirements associated with safety and protection of workers, environment, and site.
- Ability to work different shifts and overtime as required.
- Ability to work weekends and holidays as required.
- Be able to work efficiently and handle multiple task simultaneously.
- Ability to work in groups and be a team player.