Production Operator I - East Windsor, United States - ForDoz Pharma Corp.

Description

• Operate and monitor the filling operations using cGMP and company's SOP's.

• 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 oncall and respond to any afterhour 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 log books 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

• High School Diploma plus 5+ years commercial pharmaceutical manufacturing experience.
• Demonstrate indepth 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.

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

• 8 hour shift
• Monday to Friday