Process Engineer

Process Engineer II We are a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle and serving clients worldwide through our integrated network of facilities in North America, Europe and Asia. Responsibilities The Process Engineer works to design and efficiently transfer new processes into manufacturing, optimize existing processes, ensuring the achievement of quality, yield, and capacity timelines. Drafts experimental, development, and operational studies to expand expertise in parenteral manufacturing. Ensures that work is performed in an accurate, timely, and efficient manner, and in compliance with company policies, SOPs, cGMP regulations, and FDA regulations. Contributes to resolving deviations, investigations and continuous improvements to improve processes, quality, costs, safety and/or cycle time. Interfaces with Operations, Validation, Quality Assurance groups and Formulation Development to identify new components and/or processes into the existing manufacturing environment. Take initiative to develop and improve procedures and setups through the change control process. Prepares and reviews technical documents to include but not limited to: Technical Reports, SOPs, Master Batch Records (MBRs), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols. Contributes to investigations and deviations related to manufacturing, defines root causes and implements corrective actions. Troubleshoots and investigates manufacturing problems, monitors the processes and optimizes processes as required. Qualifications Bachelor of Engineering (Chemical) Equal Employment Opportunity PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions. #J-18808-Ljbffr