Technical Skills, Knowledge, and Experience
• 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.
Non-Technical Skills:
Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others’ perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.