Process Engineer I

The hiring company, located in Durham, NC, is a distinguished player in the life sciences and manufacturing sector, specializing in advanced sterilization technologies critical to ensuring the safety and efficacy of medical devices and other sensitive products. Operating onsite, they emphasize innovation and quality, particularly in terminal sterilization processes using state-of-the-art equipment and technologies such as radiation, electron beam, and gamma irradiation. This company serves diverse markets including medical device manufacturing, where stringent quality and safety standards are paramount. Their commitment to maintaining a high standard of product sterilization ensures compliance with international standards and supports advancements in healthcare safety. The role of Process Engineer I is a vital position within the organization, offered on a 12-plus month contract basis. This is a full-time role that requires a highly motivated individual who will be responsible for supporting sterilization technology and terminal sterilization processes across the division. The position involves active collaboration with cross-functional teams including Operations, Quality, Engineering, and Division Engineering to support development, engineering, and manufacturing projects. The engineer’s primary responsibility includes supporting internal sterilization equipment, processes, and technology, and liaising effectively with external vendors. This role demands an individual who can respond swiftly to production and process upsets, implement corrective actions, and optimize process capabilities using engineering principles and first-hand technical knowledge. The Process Engineer I will also be expected to provide technical leadership in assigned processes, support validation and routine sterilization activities, and ensure continuous improvement. With an emphasis on operational efficiency and product quality, this engineer will also train maintenance and operations personnel and oversee change control documentation processes. This position suits candidates with a minimum of a bachelor’s degree in engineering, material science, physics, or related sciences, with 0-3 years of experience in engineering or manufacturing environments. Advanced skills in Excel, Word, and PowerPoint are required, and experience or familiarity with radiation technology or sterilization methods is advantageous though not mandatory. The company offers an opportunity to grow as a subject matter expert in sterilization technologies, with potential exposure to life sciences, medical device quality systems, and validation protocols. The work schedule is Monday to Friday, 8 AM to 5 PM with one hour lunch, with potential occasional overtime or flexible hours to meet business needs. This position has no travel requirements. The role provides a dynamic and challenging environment where innovative problem solving, cross-organizational collaboration, and continuous learning are integral. Candidates will engage with industry standards such as ISO 11135, ISO 14937, ISO 11137, and others related to sterilization and medical device quality assurance. Overall, this opportunity is ideal for early-career engineers seeking a specialized role in sterilization process engineering within a reputable company in the life sciences space, offering both hands-on technical challenges and collaborative team dynamics to foster professional growth and impact product safety and quality.