Our client is looking to fill the role of Quality Engineer. This is Onsite daily in Sanford, NC, We are seeking an experienced Senior Quality Engineering Consultant / Lead to provide quality engineering leadership and compliance oversight during the startup and operational readiness of Kyowa Kirin's new greenfield manufacturing site in Sanford, North Carolina. This individual contributor consulting role will play a critical part in establishing and sustaining GMP-compliant quality engineering processes supporting Facilities, Utilities, Maintenance, Equipment (FUME) systems, associated instrumentation, and asset lifecycle management programs. Working closely with the Quality Engineering Lead, this consultant will serve as a trusted quality partner to Engineering, Validation, Maintenance, Manufacturing, and Digital teams to ensure inspection readiness, regulatory compliance, and operational excellence throughout site startup and ongoing operations.
Responsibilities:
Quality Engineering Leadership
- Provide Quality Engineering leadership and guidance for the Sanford site, supporting quality standards, governance, workflows, and sustainable compliance practices.
- Support site startup and GMP readiness activities across facilities, utilities, equipment, instrumentation, manufacturing processes, and supporting documentation.
- Drive quality strategies that enable compliant and efficient operations while supporting business and project objectives.
Validation, Qualification & Compliance
- Provide quality oversight for qualification and validation activities associated with equipment, facilities, utilities, and manufacturing systems.
- Review and assess engineering drawings, P&IDs, turnover packages, validation documentation, and lifecycle records to ensure systems are fit for intended use.
- Support lifecycle management activities while maintaining inspection-ready status across all assigned assets and systems.
Risk Management & Change Control
- Lead and facilitate quality risk assessments, including FMEA and hazard analyses.
- Provide quality leadership for change control processes, ensuring risks are appropriately assessed, mitigated, documented, and approved.
- Ensure all activities comply with GMP requirements, data integrity expectations, 21 CFR Part 11 regulations, and ALCOA++ principles.
Problem Solving & Continuous Improvement
- Lead structured problem-solving efforts related to equipment, utilities, facilities, instrumentation, preventive maintenance, and calibration programs.
- Support investigations, deviations, CAPAs, and corrective action implementation.
- Drive continuous improvement initiatives that enhance quality, compliance, and operational effectiveness.
Audit & Inspection Readiness
- Partner with cross-functional teams to develop and maintain inspection-ready documentation and processes.
- Support internal audits, external audits, and regulatory inspections, including preparation, execution, response development, commitment tracking, and follow-up activities.
- Review and approve, as applicable, work orders, CQV protocols and reports, change controls, deviations, CAPAs, and related quality documentation.
Cross-Functional Collaboration
- Collaborate with Engineering, Validation, Manufacturing, Maintenance, Digital, and Quality teams to achieve project milestones and compliance objectives.
- Provide technical guidance to project stakeholders and consulting partners.
- Escalate significant quality, compliance, schedule, or readiness risks to senior leadership as appropriate.
Required Qualifications:
Education
- Bachelor's degree in Engineering, Science, or a related technical discipline required.
- Master's degree preferred.
Experience
- Minimum of 8 years of experience within a GxP-regulated pharmaceutical, biotechnology, or life sciences environment, with a strong focus on Quality Engineering.
- Demonstrated experience supporting:
- Qualification and validation programs
- Change control management
- Quality risk assessments
- Deviations and CAPAs
- GMP readiness and compliance initiatives
- Experience supporting facilities, utilities, equipment, instrumentation, preventive maintenance, calibration programs, and asset lifecycle management.
- Working knowledge of data integrity requirements, 21 CFR Part 11, and ALCOA++ principles.
- Experience supporting regulatory inspections and maintaining inspection-ready documentation strongly preferred.
Preferred Experience:
- Biologics manufacturing experience, particularly within drug substance and single-use processing environments.
- Greenfield facility startup experience.
- Manufacturing readiness and operational commissioning experience.
- Cross-functional integration within large-scale pharmaceutical or biotechnology projects.
If you meet the required qualifications and are interested in this role, please apply today.
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