Kyowa Kirin is a fast-growing global specialty pharmaceutical company seeking a Quality Engineer, FUME Lead to lead and ensure quality and compliance during the startup and operation of its Sanford, NC greenfield site. The role is responsible for building, implementing, and sustaining Quality Engineering processes that enable GMP operations and long-term regulatory compliance and inspection readiness.
Requirements
- Act as the Quality Engineering lead for the Sanford site, owning priorities and outcomes and establish clear standards, workflows, and governance to ensure consistency and sustainability as the site grows.
- Lead and provide Quality oversight of GMP readiness activities for facility startup, including equipment, utilities, facilities, and process validation and documentation generation.
- Sustain compliance through lifecycle management of FUME systems, continuous improvement, and ongoing inspection readiness; confirm readiness of systems by reviewing evidence such as drawings, P&IDs, validation deliverables, and turnover packages to ensure fitness for intended use.
- Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, PMs, and calibrations and contribute to the creation of the Preventative Maintenance (PM) and calibration programs, including review of plans, intervals, and criticality assessments.
- Execute and/or provide quality technical leadership of change controls and risk assessments (e.g., FMEA, hazard analysis), including defining risk strategy, ensuring appropriate mitigation, and approving risk acceptance decisions of FUME systems.
Benefits
- 401K with company matching
- Annual Bonus Program
- Generous PTO and Holiday Schedule
- Healthcare Benefits
- HSA & FSA Programs
- Well-Being and Work/Life Programs
- Long-Term Incentive Program
- Life & Disability Insurance
- Concierge Service
- Pet Insurance
- Tuition Assistance
- Employee Referral Awards
