Senior Specialist, Quality Engineer

About the role

The Senior Specialist, Quality Engineer supports quality and compliance during the startup and operation of Kyowa Kirin’s Sanford, NC Greenfield site. This role provides hands-on Quality Engineering support and technical quality oversight for facilities, utilities, equipment, maintenance, associated instruments, computerized systems, asset lifecycle systems, and Drug Substance manufacturing processes.

Responsibilities

• Implement and sustain assigned Quality Engineering processes for the Sanford site, executing priorities and deliverables in alignment with established standards, workflows, and governance.
• Provide Quality oversight and technical review of GMP readiness activities for facility startup, including equipment, utilities, facilities, process validation, and associated documentation generation.
• Own assigned Quality Engineering activities related to facilities, utilities, manufacturing equipment, and associated instruments, including review of applicable drawings, P&IDs, turnover packages, validation deliverables, maintenance documentation, and other evidence supporting fitness for intended use.
• Manage assigned lifecycle activities for facilities, utilities, manufacturing equipment, and associated instruments through change controls, deviations, CAPAs, periodic reviews, maintenance and calibration documentation, and continuous improvement activities.
• Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, preventive maintenance, and calibrations, ensuring actions are appropriately documented, risk-based, and aligned with GMP expectations.
• Execute risk assessments, including FMEA, hazard analysis, criticality assessments, and quality impact assessments; recommend mitigation actions and escalate risk acceptance decisions as appropriate.
• Review and provide Quality input for work orders, commissioning and qualification documentation, validation protocols and reports, change controls, deviations, CAPAs, and procedures associated with assigned Quality Engineering activities.
• Ensure assigned activities are consistent with data integrity expectations, 21 CFR Part 11 requirements, ALCOA+ principles, and applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System.
• Partner with Engineering, Validation, Maintenance, Manufacturing, IT, and Quality stakeholders to maintain inspection-ready documentation and enable compliant execution of startup, operational, and quality system activities.
• Execute audit and inspection readiness actions for assigned Quality Engineering and quality system activities by preparing documentation, participating in walkthroughs, fulfilling requests, and completing assigned follow-up actions.
• Identify quality risks, documentation gaps, and process improvement opportunities within assigned scope and communicate them promptly to the Quality Engineer Lead and Quality Systems & Compliance management.

Requirements

• Education: Bachelor’s degree in Life Sciences, Pharmaceutical Sciences or related field.
• Experience: Minimum 5 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering; including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.
• Skills: Demonstrated experience in qualification, validation, change control, and Quality Engineering activities. Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred. Familiarity with single-use DS biologics operations or greenfield startup environments is preferred.

Physical Demands

• Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE.

Working Conditions

• Requires up to 10% domestic and limited international travel.

Compensation and Benefits

The anticipated salary for this position will be $116,000 to $152,300. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications), location, and other business and organizational needs. The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 401K with company matching
• Annual Bonus Program (Sales Bonus for Sales Jobs)
• Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
• Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
• HSA & FSA Programs
• Well-Being and Work/Life Programs
• Long-Term Incentive Program (subject to job level and performance)
• Life & Disability Insurance
• Tuition Assistance
• Employee Referral Awards

This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.