Senior Quality Engineer

Key Responsibilities

• Provide quality oversight for pharmaceutical packaging, labeling, and serialization operations
• Support automated and high-speed packaging line activities within a GMP environment
• Manage investigations, deviations, CAPAs, and change controls related to packaging and labeling events
• Review and approve SOPs, batch record documentation, and packaging specifications
• Support validation and qualification activities for packaging equipment and labeling systems
• Partner cross-functionally with Manufacturing, Engineering, Technical Services, and Supply Chain teams
• Ensure inspection readiness for FDA, EMA, and client audits
• Support defect investigations, label reconciliation, and packaging compliance initiatives
• Drive continuous improvement efforts across packaging quality systems
• Maintain compliance with serialization and track-and-trace requirements

Qualifications

• 5+ years of experience in pharmaceutical or biotech Quality Assurance
• Direct experience supporting packaging, labeling, or serialization operations in a GMP-regulated environment
• Experience within sterile injectable, biologics, or other highly regulated manufacturing environments preferred
• Strong understanding of deviations, CAPAs, risk assessments, and validation activities
• Familiarity with automated packaging technologies and serialization platforms
• Experience supporting FDA and/or EMA inspections
• Strong communication skills with the ability to work across multiple departments