Process Engineer I

Process Engineer I - Process DevelopmentContract Development and Manufacturing Organization is seeking a Process Engineer to join their team on a direct hire basis.The Process Engineer is responsible for the evaluation, design, and implementation of elements of new or improved processes as they are transferred from development to production. Monitor manufacturing processes while providing production support and ensuring compliance with safety and quality standards. Collaborate with cross-functional teams and external customers to implement safe, efficient, practical, and commercially viable processes to generate a consistent quality API supply fit for its intended use, prioritizing safety, quality, process yields, turnaround times, and productivity. Lead process improvement efforts to enhance yields and lower production costs, improving overall efficiency and cost-effectiveness of production processes. Contribute to the design and oversight of scale-up and validation runs in the manufacturing plant. Collaborate with Project/Facilities Engineering during front-end design, PHA, design reviews, commissioning, start-up, and operator training. Use root cause analysis tools to lead troubleshooting efforts related to processing and process equipment problems, gathering relevant information and compiling reports. Write and review Batch Records, Process Safety Information, Process Validation Protocols, Operator training, and other technical reports. Collaborate with the EHS group on environmental, health, and safety aspects of new processes and process modifications, including emission calculations. Develop process performance tracking procedures and analyze existing data for optimization potential.B.S. in Chemical Engineering or equivalent technical degree. Minimum of 3 years' manufacturing or process engineering experience in pharmaceuticals or batch processing. Advanced knowledge of Microsoft Office Products (Word, Excel, and PowerPoint). Knowledge of equipment, technical concepts, and procedures within bulk API batch manufacturing.System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.