Quality Engineer

Quality Engineer

Our client is looking to fill the role of Quality Engineer. This is Onsite daily in Sanford, NC

Pay Range - $65-$70/hour

• Lead and provide Quality oversight for GMP readiness activities associated with facility startup, including equipment, utilities, facilities, process validation, and associated documentation
• Review and approve qualification and validation deliverables for DS manufacturing equipment, utilities, facilities, and processes
• Assess system readiness and review supporting evidence (e.g., drawings, P&IDs, turnover packages) to confirm fitness for intended use
• Support the development of Preventive Maintenance (PM) and calibration programs, including review of strategies, frequencies, and criticality assessments
• Execute and/or provide quality leadership for change controls and risk management activities (e.g., FMEA, hazard analyses)
• Apply structured problem-solving approaches to address issues related to equipment, utilities, facilities, calibration, and PM programs
• Ensure all activities align with data integrity expectations, 21 CFR Part 11 requirements, and ALCOA++ principles
• Partner with Engineering, Validation, and Maintenance teams to maintain accurate, inspection-ready documentation and asset status
• Collaborate cross-functionally to support startup milestones and ensure compliant execution of activities

• Bachelor's degree in Engineering or a related discipline
• Minimum of 5 years of experience in a GxP-regulated environment, with a focus on Quality Engineering
• Demonstrated experience with qualification, validation, change control, and quality engineering activities
• Experience with PM and calibration programs, equipment lifecycle management, or CMMS platforms strongly preferred
• Familiarity with drug substance single-use biologics operations and/or greenfield startup environments preferred

If you meet the required qualifications and are interested in this role, please apply today.

The Solomon Page Distinction

Solomon Page offers a comprehensive benefit program for hourly employees. We pride ourselves on offering medical, dental, 401(k), direct deposit and commuter benefits to our employees, including freelancers - which sets us apart in the industries we serve.

About Solomon Page

Founded in 1990, Solomon Page is a specialty niche provider of staffing and executive search solutions across a wide array of functions and industries. The success of Solomon Page reflects an organic growth strategy supported by a highly entrepreneurial culture. Acting as a strategic partner to our clients and candidates, we focus on providing customized solutions and building long-term relationships based on trust, respect, and the consistent delivery of excellent results.