Quality Engineer
- Pay Range - $58-$63/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
Opportunity Awaits.
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