Process Engineer I
- Reference ID: Process Engineer I
- Type: Full-Time Position
Medefil, Inc. seeks Process Engineer I in Glendale Heights, IL: Monitor the performance of processes, equipment, and product to make recommendations for continuous improvement. Sustain manufacturing processes. Responsible for operation, maintenance, and calibration of Water for Injection, Pure Steam and Reverse Osmosis Feed Water generation, storage and distribution systems, equipment and finished product autoclaves and equipment and process control and monitoring systems. Responsible for operation, maintenance and inspection/certification of plant steam boilers and chillers. Lead project manager and key vendor contact for new equipment design, quotation, procurement, FAT/SAT qualification, placement into service and training. Use DMAIC approach to investigate, recommend, justify and implement new technologies, manufacturing methods and equipment to meet competitive business needs and improve efficiencies. Assist in development of P&IDs for CIP, SIP, product transfer of bulk manufacturing equipment and processes for upcoming production facility. Execute/assist in Commissioning, Qualification, and Validation of new equipment. Presentation of critical system design and qualification documents during internal and external regulatory (FDA, ISO, OSHA) business partners and contract business client audits. Ontime scheduling of testing of effluent water and preparation and submission of quarterly effluent water reports to the Village. Modify/develop/execute preventative maintenance procedures and spare parts inventory. Oversee scheduling for on-time completion and perform/review in-house and external preventive maintenance of equipment and calibration program for process instrumentation. Conduct troubleshooting and technical analyses on manufacturing equipment and processes systems consisting of a wide variety of electro-mechanical components, including sensors, safety components, pneumatics, drive systems, etc. Update and review CAD drawings and perform 3D modelling. Planning, documentation and execution of plant projects involving equipment changes and process improvements. Propose, document and implement Corrective and Preventative Actions (CAPAs) and participate in quality risk assessments and assist the QA Department with GMP compliance. Create/review/revise engineering and manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, and error prevention activities. Complete investigation reports relating notice of event, nonconformance report, and out of specification events for equipment and processes. Perform root cause, GAP, SWOT, and statistical analysis as required for investigations and process improvement projects. Document processes and train operators and other personnel. Provide engineering support to quality control, drug development, and manufacturing departments. Develop, update, and peer-review engineering documents such as instructions, drawings, test procedures, and reports. Design and revise clean room’s layout, personnel/material/bulk/tank flow, differential pressure plan of rooms in compliance with ISO 14644 standards for facility expansion. Design and revise equipment layout for facility expansion required from bulk formulation until end product packaging as per requirements. Generate protocols and reports for Installation, Operational, and Performance Qualification.
Requirements: Master’s degree in Mechanical Engineering, Industrial Engineering or related field. Email resume to sandeep.aggarwal@medefilinc.com for consideration.
Schedule:
Monday-Friday: 9:00 am to 5:00 pm