Process Engineer
MSD
Total des années d'expérience :14 years, 3 Mois
• Working in classified areas (Class C), this includes CNC awareness and gowning trained
• G.D.P proficient
• Trained and working in cGMP environment
• Run time efficiency and tracking production downtime of the sterile processing equipments (IMA capper)
• SOP’s update fowling change in a processes
• Process analysis and improvement using problems solving tools such as SPS including: 5 whys technique, VSM and LSS
• Design system in accordance to project specification and requirements.
• Carry out inspection of the equipment upon delivery SAT.
• Provide support during the following stages : assembly, testing, site commissioning and warranty.
• Process improvement and optimization projects
• Process troubleshooting
• Support operations to ensure compliance with all quality assurance and validation requirements
• Working with other departments such as accountants and human resources personnel, to manage operations.
• Monitoring performance of equipment, machines and tools, troubleshooting manufacturing process.
• Process documentation and calibration and preventative maintenance of equipment.
Drug production, function and manufacturing, Pharmaceutical process technology, Pharmaceutical process for sterile products, Pharmaceutical biotechnology process
Process Validation within the Quality Management System, Installation qualification (IQ)- equipment design , safety, Operational qualification(OQ) - software , raw materials inspections, Performance qualification (PQ) - final product acceptance, process acceptance
Computer facilities and programming, Mathematical simulation, Theoretical Mechanics, Resistance of Materials, Technological processes of machine-building production, Science of materials, electrical engineering and electronics, hydraulics and hydraulic drives, cutting theory, thermal processes, machine equipment of automatic production, automatic control and theory of technological systems