Quality Engineering Specialist

Quality Engineering SpecialistJob ID: 36769735 Location: Athens, GA (Onsite) Contract: 12 Months Shift: First Shift | Hours: 8:00 AM - 5:00 PM About the Role Sigma Systems is seeking an experienced Quality Engineering Specialist to support manufacturing operations and site capital projects within a regulated Animal and Human Health environment. This role plays a critical part in ensuring GMP compliance, leading quality activities for OPEX and CAPEX projects, and supporting facility, utilities, and equipment upgrades. The ideal candidate brings hands-on quality engineering experience in biologics or vaccine manufacturing, with a strong background in change control, validation, deviation management, and project quality leadership. Key Responsibilities Provide quality assurance support for production operations and site capital projects Serve as Quality Lead for OPEX and CAPEX projects, supporting: Change controls Project documentation Facilities, utilities, and infrastructure upgrades Act as a technical and compliance resource on internal and external project teams Support and resolve quality-related issues, deviations, and validation discrepancies Participate in technology transfer, commissioning, and equipment qualification activities Drive a strong quality culture through proactive problem-solving and continuous improvement Ensure compliance with GMP and regulatory requirements throughout project lifecycles Required Qualifications Bachelor's degree in Life Sciences, Engineering, or a related discipline 5+ years of experience in Animal Health or Human Health industries Proven experience supporting: Manufacturing operations Quality engineering Capital or site improvement projects Strong working knowledge of: Change control systems Deviation and discrepancy management Equipment validation and qualification Experience with vaccine products or biological manufacturing processes Demonstrated ability in: Advanced problem-solving Project coordination Influencing and sustaining a strong quality culture Preferred Qualifications Project experience supporting: Commissioning of new facilities or infrastructure Utilities systems (HVAC, water, clean utilities, etc.) Experience with process excellence / OPEX initiatives Background working in GMP-regulated pharmaceutical or biotech environments

Created: 2026-03-04