- Provide technical support and troubleshooting expertise to the Daily Operational Team to ensure sterile injectable products are manufactured in accordance with Standard Operating Procedures, current Good Manufacturing Practices and Safety Policies
- Provide technical support and troubleshooting expertise to the Daily Operational Team.
- Be able to solve routine engineering problems with minimal assistance
- Utilize analytical skills and critical thinking to perform in-depth system investigations and problem solving
- 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.
- Lead and 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
- Act as main cross functional contact for the execution of equipment qualification activities.
- Serve as a back-up to the production manager to monitor and oversee the production
- Support design and qualification of manufacturing facility and equipment,
- Actively participate in technology transfer
- Support Pilot Test Runs, Validation Runs, Engineering Runs and other requirements needed
- Complete other duties and tasks as assigned
- Bachelor degree in chemistry, chemical engineering or other scientific discipline or related field, plus 5+ years commercial pharmaceutical manufacturing experience.
- Demonstrate in-depth understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation
- Flexible work hours and schedules
- Strong problem solving and analysis skill
- 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.
- Knowledge of injectable products compounding and filling line is a plus
- Knowledge of the electrical, mechanical and logistics equipment used in manufacturing, including its safe usage, maintenance and storage
- Knowledge of technologies and applications used in manufacturing products and in the optimization of manufacturing processes
- Experience and knowledge of HVAC systems, clean rooms, sanitary processing, sterilization equipment, and WFI systems, computer control systems, cleaning processes and aseptic manufacturing
- Be able to work efficiently and handle multiple task simultaneously
- Has excellent communication skills (both oral and written).
- Work hard and a good team player
ForDoz Pharma Corp. is a specialty pharmaceutical company focusing on development, manufacturing, and commercialization of complex generic products (e.g. oncology and antifungal products) and improved existing products 505(b)(2). ForDoz Pharma Corp. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other legally protected characteristics
Job Type: Full-time
Salary: $50,000.00 to $100,000.00 /year