Principal Engineer – Visual Inspection

Key Responsibilities

• Monitor and trend process performance, reject rates, and defect trends, and leverage insights to drive operational decisions.
• Apply statistical tools (e.g., capability, control charts) to understand process variability, optimize machine parameters, and reduce false reject rates while maintaining detection capability.
• Ensure all inspection systems — automated visual inspection (AVI) machines and manual inspection stations — remain in a qualified state and fit for intended use.
• Review and improve maintenance and calibration programs for inspection equipment.
• Support implementing key digital upgrades and initiatives from a process engineering perspective ensuring they meet the process needs.

Serve as Subject Matter Expert for:

• Automated Visual Inspection (AVI): machine qualification, recipe development and management, and ongoing performance monitoring.

Training and Mentorship

• Train and mentor engineers in data analysis, problem-solving, inspection system design, and execution excellence.
• Review and approve documentation requiring Responsible Engineer deliverables and GMP documentation, as applicable (e.g., SOPs, batch record changes, validation protocols/reports, change controls, inspection specifications).
• Lead or support investigations, root cause analyses, and countermeasure implementation for equipment-related deviations.
• Manage and coordinate original equipment manufacturer (OEM) relationships critical to formulation and component preparation equipment reliability (e.g., service strategy, troubleshooting, spares, upgrades).

Regulatory Compliance and Support

• Support preparation and review of regulatory filings and responses related to inspection processes (inspection method descriptions, validation summaries, responses to agency queries).
• Define project scope, user requirements, and technical deliverables for capital projects, and process improvement initiatives related to inspection technologies and workflows.
• Sponsor and manage inspection method validation and AVI qualification activities.
• Lead evaluation and implementation of new inspection platforms or vision system upgrades.

Leadership and Collaboration

• Coach and mentor junior and mid-level engineers in visual inspection science and technology.
• Promote standardization of inspection procedures, defect classification, and documentation quality across shifts and product lines.
• Support development of training materials and qualification programs for inspectors and cross-functional teams.