Process Improvement Engineer

Position Title: Process Improvement Engineer Position Type: Long-Term Contract (High potential of extension or conversion) Location: Concord, NC Department: Engineering – Manufacturing Position Overview: We are seeking a Process Improvement Engineer to lead initiatives within our Concord, NC manufacturing site. This role will focus on driving continuous improvement, process optimization, and mechanical efficiency enhancements across high-speed, regulated production environments. The ideal candidate will be passionate about identifying inefficiencies, leading data-driven improvement projects, and collaborating with cross-functional teams to implement sustainable solutions that improve output, quality, and reliability. Key Responsibilities: 1. Process Optimization & Continuous Improvement • Lead efforts to identify, analyze, and implement improvements that reduce cycle time, enhance equipment reliability, and increase throughput. • Utilize Lean, Six Sigma, and data analytics tools to streamline packaging and assembly processes. • Partner with operations and engineering teams to reduce process variability and eliminate bottlenecks. • Champion automation, standardization, and error-proofing (poka-yoke) across systems and workflows. 1. Cross-Functional Project Leadership • Serve as a technical leader for improvement initiatives involving equipment upgrades, process changes, or new product introductions. • Collaborate with Manufacturing, Maintenance, Quality, and Validation teams to ensure smooth integration of process improvements. • Support equipment commissioning, qualification, and process validation. • Lead troubleshooting efforts using root cause analysis (RCA) and structured problem-solving methodologies. 1. Compliance, Safety & Risk Mitigation • Drive improvements with a strong focus on compliance with GMP, safety standards, and regulatory guidelines. • Conduct and support risk assessments, safety audits, and mitigation planning for new or modified processes. • Foster a culture of proactive safety and compliance on the production floor. 1. Technical Documentation & Knowledge Transfer • Develop and maintain robust documentation, including process maps, SOPs, work instructions, and training guides. • Provide training and coaching to operators, engineers, and maintenance staff on process changes and best practices. • Ensure all improvements are captured and sustained through proper documentation and knowledge sharing. 1. Performance Monitoring & KPI Management • Define and monitor key process performance indicators (KPIs) to track project success and identify new opportunities. • Use data visualization and reporting tools (e.g., Excel, Power BI) to share insights and influence decision-making. • Create and maintain dashboards to visualize trends and assess ROI on improvement efforts. Minimum Qualifications: • Bachelor’s Degree in Engineering (Mechanical, Industrial, Chemical, or a related field). • 3+ years of experience in a manufacturing or assembly environment, preferably in packaging, medical devices, or pharmaceuticals. • Demonstrated success in leading process improvement projects in a regulated environment. • Experience working with automated systems, manufacturing equipment, and process optimization tools. • Strong problem-solving skills and proficiency with data analysis tools. Preferred Qualifications: • Experience in pharmaceutical, biotech, or medical device industries. • Hands-on knowledge of automated packaging and device assembly lines. • Certification in Lean Six Sigma (Green Belt or higher). • Familiarity with GMP standards, process validation, and equipment qualification (IQ/OQ/PQ). • Project management experience leading cross-site or multi-disciplinary improvement initiatives. Additional Information: • This position is based in Concord, NC and will require periodic travel to domestic sites and suppliers for project support. • Flexibility for off-hours or weekend support may be required depending on project timelines and production needs. • Potential travel locations include Raleigh, Cincinnati, Philadelphia, and Indianapolis. Eight Eleven Group (Brooksource) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.