Process Engineer Position Available In Pitt, North Carolina

Process Engineer Job Description Join a dynamic team providing round-the-clock technical support and expertise to sterile pharmaceutical production. This role involves assisting Customer Facing Process Engineers with technical transfers, process modifications, and auxiliary support systems. You will initiate process improvements to enhance safety, reduce costs, improve quality, and boost Overall Equipment Effectiveness (OEE). Emphasize minimizing equipment downtime to increase availability and efficiency while ensuring regulatory compliance. Responsibilities Provide technical expertise and support to meet business unit objectives and increase production’s Overall Equipment Effectiveness (OEE). Maintain system design and associated documentation. Diagnose and resolve complex process and equipment interactions to ensure system readiness, often collaborating with other teams. Communicate resolution summaries to Area Leadership. Serve as Subject Matter Expert (SME) on equipment and process functionality for production and utilities. Develop process flow diagrams, problem-solving guides, and advanced troubleshooting aides to enhance process efficiencies and repeatability. Train internal resources to increase technical knowledge in Steriles East. Provide SME input for CAPEX Equipment Upgrades on Sterile Fill/Finish processing equipment to ensure regulatory compliance, quality requirements, and line efficiency. Coordinate planned interruptions of processing areas or entire building during shutdown activities, as required. Create, modify, and approve process equipment recipes following relevant SOPs. Provide supporting data on process systems and equipment for production and quality investigations, proposing solutions and improvement opportunities. Engage in daily floor interactions with Engineering, Operations, Maintenance, Quality, and Safety, spending 70-90% of time on shift on the production floor. Collaborate with key stakeholders to prioritize line activities and resolve conflicts. Document conditions, actions, and results of work performed according to company policies and procedures in logbooks and shift reports. Drive Continuous Improvements using metrics, TPM, 5S, and the PPI process. Essential Skills Bachelor’s Degree in Engineering (Mechanical or Industrial preferred). Proven experience in process improvement with examples of affecting efficiency on production lines. Pharmaceutical or biotech industry experience preferred; food and beverage industry experience considered. Strong verbal and written communication skills. Ability to perform effectively in a team environment. Experience troubleshooting or working on an Optima line is highly desirable. Additional Skills & Qualifications BS Degree in Mechanical, Electrical, or Industrial Engineering with three years of process experience. 3+ years of Process Improvement experience using Six Sigma, Lean, 5S, Trend Analysis methodologies preferred. Experience in a regulated manufacturing environment in the Biotechnology, Pharmaceutical, or Medical Device industry is advantageous. Knowledge of Data Integrity principles for automation systems and audit trail data. Outstanding attention to detail and organizational skills to manage time and prioritize tasks. Work Environment This is an onsite position in a manufacturing area, requiring 80% of the time to be spent on the floor troubleshooting equipment and working with operations. It is a very hands-on role, not desk-bound. The position follows a 12-hour rotating shift schedule (2-2-3) with straight days or nights. You must adhere to OHS policies and procedures to ensure a safe and healthy workplace environment.