Solomon Page · 1 day ago
Quality Engineer
Sanford, NC
Contract
Onsite
Senior Level
$58/hr - $63/hr
5+ years expSolomon Page is a specialty niche provider of staffing and executive search solutions. They are seeking a Quality Engineer to lead quality oversight for GMP readiness activities associated with facility startup and ensure compliance with quality standards.
Asset ManagementConsultingProfessional Services
Responsibilities
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
Qualification
Required
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
Preferred
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
Benefits
Medical
Dental
401(k)
Direct deposit
Commuter benefits
Company
Solomon Page
Founded in 1990, Solomon Page is a leading staffing and executive search firm headquartered in New York City with offices across the United States.
1001-5000 employees
H1B Sponsorship
Solomon Page has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Lloyd Solomon
Managing Director
Rachel Tigges
CMO
Company data provided by crunchbase