Quality Engineer, Lead

Responsibilities

• Act as the Quality Engineering lead for the Sanford site, owning priorities and outcomes
• Lead and provide Quality oversight of GMP readiness activities for facility startup, including equipment, utilities, facilities, and process validation
• Sustain compliance through lifecycle management of FUME systems and continuous improvement
• Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, PMs, and calibrations
• Execute quality technical leadership of change controls and risk assessments (e.g., FMEA, hazard analysis)
• Partner with Engineering, Validation, and Maintenance Teams to maintain inspection-ready documentation
• Review and approve work orders, CQV protocols, change controls, deviations, and CAPAs

Requirements

• Bachelor’s degree in engineering or science related field
• Minimum 8+ years of direct industry experience in a GxP-regulated environment
• Demonstrated experience in qualification, validation, change control, and Quality Engineering activities
• Experience serving as a Quality SME during regulatory inspections or audits

Preferred Qualifications

• Master’s degree in engineering or science related field
• Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms
• Familiarity with DS single-use biologics operations or greenfield startup environments

About the Company

Kyowa Kirin is a Japanese-based global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in bone and mineral, hematology oncology, and rare disease areas.