Process Engineer – Pharmaceutical Manufacturing Equipment

This is a hands-on manufacturing-floor engineering role supporting automated equipment and processes within a fast-paced cGMP sterile drug-product operation. The Process Engineer will own manufacturing-equipment troubleshooting, recurring-failure elimination, reliability and process improvements, performance monitoring, and implementation of new equipment, products, and manufacturing processes.

• Provide hands-on engineering support for automated manufacturing equipment and production processes.
• Troubleshoot recurring equipment and process failures, determine root causes, and implement sustainable corrective engineering solutions.
• Lead equipment-reliability and process-improvement initiatives that improve uptime, throughput, yield, quality, scrap, cycle time, or other manufacturing KPIs.
• Establish, monitor, and trend process and equipment performance metrics to identify reliability and performance opportunities.
• Evaluate, design, modify, and implement manufacturing processes and equipment for existing and new products.
• Support installation, commissioning, startup, qualification, and operational handoff of new or modified manufacturing equipment.
• Support new-product introductions, technology transfers, and manufacturing-line implementation.
• Lead structured root-cause investigations involving manufacturing processes and equipment.
• Author and support deviations, CAPAs, change controls, risk assessments, engineering protocols, technical reports, and other controlled documentation associated with equipment and process changes.
• Partner with Manufacturing, Quality, Validation, Maintenance, Automation, Technical Services, R&D, and other functions to implement compliant engineering improvements.
• Support troubleshooting and diagnostic activities involving automated equipment, PLC/HMI-controlled systems, sensors, machine controls, and associated mechanical systems.
• Develop and maintain manufacturing procedures, equipment documentation, batch-record content, and training materials.
• Provide hands-on manufacturing-floor support during equipment failures, process changes, startup activities, and project implementation.
• Support project schedules, cost forecasts, and implementation milestones.

• Bachelor’s degree in Mechanical, Chemical, Manufacturing, Biochemical, Biotechnology, or another relevant Engineering discipline strongly preferred. Candidates with a closely related technical degree and substantial directly relevant manufacturing-equipment engineering experience may also be considered.
• Approximately 5+ years of relevant engineering experience supporting manufacturing equipment and processes.
• Experience in pharmaceutical, biopharmaceutical, medical-device, or another highly regulated manufacturing environment strongly preferred.
• Demonstrated hands-on ownership of manufacturing equipment or processes, including troubleshooting equipment failures and implementing engineering improvements.
• Ability to provide examples of identifying a manufacturing or equipment problem, determining root cause, implementing a corrective engineering change, and measuring the resulting improvement.
• Experience improving equipment reliability, downtime, throughput, yield, reject rate, scrap, cycle time, OEE, or comparable manufacturing-performance metrics.
• Experience with structured root-cause analysis and technical problem-solving.
• Experience supporting equipment installation, commissioning, startup, qualification, or manufacturing-line implementation.
• Working knowledge of cGMP requirements, validation, quality systems, document control, and the regulatory impact of equipment and process changes.
• Experience with deviations, CAPAs, change controls, engineering protocols, technical reports, risk assessments, or comparable controlled documentation.
• Strong project-management, organizational, technical-writing, and cross-functional communication skills.

• Automated visual inspection or machine-vision systems
• Vial inspection equipment
• Filling or fill-finish equipment
• Vial labeling equipment
• Pharmaceutical packaging or secondary-packaging lines
• Cartoners, case packers, conveyors, or automated material-handling equipment
• Serialization equipment
• Robotics or automated assembly systems
• Integrated automated manufacturing lines
• PLC/HMI-controlled production equipment
• Sensors,…