Process Engineer

If you’re a Process Engineer, Manufacturing Engineer, Validation Engineer, or Technical Services professional who likes solving problems where they actually happen—on the manufacturing floor, this may be the opportunity for you. This role combines process engineering, validation, technical problem-solving, technology transfer, and continuous improvement within a regulated medical device manufacturing environment. You’ll have the opportunity to take ownership of technical projects, improve established manufacturing processes, troubleshoot production challenges, and work cross-functionally with Engineering, Quality, Operations, and other site teams. WHAT YOU'LL BE DOING Lead and support IQ/OQ/PQ process and equipment validation Troubleshoot complex manufacturing and production issues Author qualification documents, validation documentation, SOPs, and technical reports Analyze process data to identify risk, inefficiencies, yield improvements, and process capability opportunities Support new product launches and technology transfers Optimize existing commercial manufacturing processes Lead technical projects from investigation through implementation Partner with Operations, Engineering, Quality, Procurement, and Operational Excellence Support equipment/process qualification and continued process verification Contribute to Lean, Six Sigma, and continuous improvement initiatives MININMUM QUALIFICATIONS 3–5+ years of Medical Device and/or Pharmaceutical manufacturing experience Background in Engineering, Science, Technology, or a closely related technical discipline Demonstrated process and/or equipment validation experience Strong technical writing capabilities Knowledge of U.S. FDA and/or EU MDR medical device regulations Experience working within a GMP-regulated manufacturing environment Strong technical troubleshooting, analytical, and problem-solving capabilities A Mechanical Engineering or Process Engineering background is particularly relevant, although candidates from other technical disciplines with comparable manufacturing experience are encouraged to apply. THE ENVIRONMENT This is an onsite, individual-contributor position for someone who enjoys having ownership. You’ll have support while learning the site's quality systems, processes, and SOPs, but ultimately we're looking for someone who is self-driven and capable of independently moving technical projects forward . The environment is collaborative and cross-functional, so success requires someone who can combine technical expertise with the ability to influence, communicate, and work effectively across teams . COMPENSATION & BENEFITS Medical: 100% company-paid medical premiums for employees and dependents 401(k): 100% company match on the first 4% of employee contributions Additional Benefits: Tuition reimbursement and additional financial wellness resources If your background sits at the intersection of manufacturing engineering, process improvement, validation, technical writing, and regulated medical device/pharmaceutical manufacturing , this is an opportunity to have meaningful ownership over how products and processes perform. #J-18808-Ljbffr