Process Engineer IV, MSAT (Visual Inspection)

Key Responsibilities

• Own all MSAT responsibilities related to visual inspection of filled container closures (automated and manual)
• Define and maintain visual inspection centerlines, critical process parameters, material fit-for-use criteria, and operating procedures to ensure process capability
• Serve as site SME for visual inspection equipment and processes
• Lead continuous improvement efforts including changeover reduction, yield improvements, OEE improvements, maintenance reliability, and waste reduction for automated inspection equipment
• Define success criteria for technology transfer and process validation; ensure processes are capable before handoff to Manufacturing
• Generate URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols and reports
• Perform and maintain risk management activities for new and existing processes and equipment
• Lead process validation activities required as a result of changes to validated manufacturing processes
• Participate in annual product reviews and biennial critical systems reviews
• Initiate deviations and lead or facilitate technical investigations and impact assessments
• Identify, develop, and manage change controls to improve processes and address root causes
• Author, review, and approve SOPs, batch records, rework procedures, validation documents, and change requests
• Career Development
• Coordinate equipment data, capabilities, utilization, efficiencies, and lifecycle management
• Own user requirements for new asset procurement
• Develop project justifications and engineering proposals, including input to the capital planning process
• Maintain external technical relationships with equipment and material suppliers
• Operations Support
• Identify technical training needs for Operations, Engineering, and Maintenance
• Provide on-call support as required
• Serve as key technical contact during regulatory inspections

Minimum Qualifications

• Significant experience supporting manufacturing operations in a regulated or cGMP environment
• Demonstrated experience in visual inspection processes, automated vision systems, and process validation or technology transfer in pharmaceuticals or a comparable GMP environment
• Experience identifying, justifying, implementing, and testing process improvements in a cGMP environment
• Established track record as a technical SME in visual or process engineering

Preferred Qualifications

• Bachelor's degree in Engineering or a related technical discipline
• Experience with both automated and manual visual inspection
• Project management experience, including leading equipment installation and qualification efforts
• Six Sigma or analytical troubleshooting skills
• Experience in a LEAN manufacturing environment
• Proficiency with quality management systems (deviations, change controls, CAPAs)
• Ability to coach and mentor peers