Senior Specialist, Quality Engineer

Kyowa Kirin • Sanford, NJ

2d • Onsite

About The Position

The Senior Specialist, Quality Engineer is a key individual contributor role within the Quality Systems & Compliance team supporting 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. Working under the direction of the Quality Engineer Lead and Sr. Manager, Quality Systems & Compliance, this role helps implement and sustain Quality Engineering processes that enable GMP operations, regulatory compliance, audit defense, and compliant risk-based decision making across manufacturing-related systems. The Senior Specialist is expected to own assigned Quality Engineering deliverables and workstreams, provide technically sound recommendations, and escalate risks, gaps, or decisions requiring lead or management alignment. The role supports inspection readiness by preparing quality evidence, maintaining documentation discipline, and contributing to responses, commitments, and follow-up actions from regulatory inspections, internal audits, and external audits. As an individual contributor, you will take a compassionate and people-focused approach to your work while collaborating with other functional groups, both internal and external, to create a supportive and inclusive environment that align with the organization’s values. Strong interpersonal skills, acknowledging diverse viewpoints, and building cross functional relationships will be the key driver to make decisions that meet both individual and team needs. Key drivers for this role require accountability/ownership for delivering results and completing tasks, adapting to challenges while taking the initiative to problem solve with opportunities to grow, helping achieve business goals and keeping the patient first.

Requirements

• Bachelor’s degree in Life Sciences, Pharmaceutical Sciences or related field
• 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.
• Demonstrated experience in qualification, validation, change control, and Quality Engineering activities.
• Familiarity with single-use DS biologics operations or greenfield startup environments is preferred.

Nice To Haves

• Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred

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.

Benefits

• 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
• Concierge Service
• Pet Insurance
• Tuition Assistance
• Employee Referral Awards

What This Job Offers

• Job Type: Full-time
• Career Level: Senior