Process Engineer I

The hiring organization is a prominent company located in Durham, North Carolina, specializing in advanced sterilization technologies and processes. This company operates within a dynamic and highly regulated industry, focused on delivering quality manufacturing solutions primarily for the life sciences and medical device sectors. Known for its commitment to innovation and operational excellence, the company prioritizes collaboration across various departments such as Operations, Quality, Engineering, and Division Engineering to maintain superior standards and meet stringent regulatory requirements. The position offered is a 12-plus months contract opportunity, requiring 100% onsite presence in Durham, NC, with working hours typically from 8 AM to 5 PM Monday through Friday, including a one-hour lunch break, and potential overtime as needed. Interviews for this role involve an initial phone screening followed by an on-site panel interview, emphasizing the company's thorough selection process to find the best fit for their teams. The role of Process Engineer I is integral to supporting sterilization technology and terminal sterilization processes across the division. The primary responsibility lies in supporting internal sterilization equipment, process, and technology while interfacing with external vendors to ensure optimal performance and continuous process improvements. The engineer will support development, engineering, and manufacturing projects, collaborating closely with cross-functional teams to improve operational efficiencies and product quality. The position demands technical leadership and problem-solving expertise, particularly in troubleshooting production issues, conducting root cause analysis, and implementing corrective actions swiftly to prevent downtime. A key focus of this role is to maintain a high level of uptime for sterilization equipment, targeted at 98%, through proactive monitoring and maintenance strategies. In this position, the candidate will actively engage with site engineers, operations personnel, and suppliers to maintain and enhance operations. Responsibilities include the management and refinement of Statistical Process Control (SPC) and Statistical Quality Control (SQC) to ensure disciplined process control and continuous development of core process capabilities. The role also involves supporting validation, routine sterilization, and requalification activities to maintain compliance and operational readiness. As a Process Engineer I, the individual will lead or contribute to project teams focused on commercial product support, continuous improvement initiatives, innovation projects, and other sterilization-related activities. This role promotes a culture of knowledge sharing and operational excellence by training maintenance and operations personnel on sterilization machinery and processes to ensure technical proficiency and product quality. The candidate must exhibit flexibility in their working schedule to accommodate business needs. Indirect leadership is also an essential aspect, guiding technical and hourly associates to meet departmental goals related to quality, quantity, service, cost, and safety. Overall, this role offers a challenging yet rewarding environment where the engineer can grow their expertise in sterilization technology and contribute significantly to the success of the organization’s manufacturing operations, making a direct impact on product safety and efficacy in highly regulated industries.