Senior Quality Engineer - Packaging & Labeling

Harba; Indianapolis (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Harba is seeking an experienced Quality Assurance professional for its pharmaceutical packaging division in Indianapolis, Indiana. The successful candidate will provide quality oversight for packaging, labeling, and serialization operations in a GMP environment.

The role requires strong communication skills and the ability to manage investigations, deviations, and CAPAs effectively while ensuring compliance with serialization requirements and FDA regulations.

Qualifications

• 5+ years of experience in pharmaceutical or biotech Quality Assurance.
• Direct experience supporting packaging, labeling, or serialization operations in a GMP-regulated environment.
• Familiarity with automated packaging technologies and serialization platforms.

Responsibilities

• Provide quality oversight for pharmaceutical packaging and labeling operations.
• Manage investigations, deviations, CAPAs, and change controls related to packaging events.
• Ensure inspection readiness for FDA, EMA, and client audits.

Skills

Quality Assurance in pharmaceutical

Experience with GMP environments

Strong communication skills

Understanding of CAPAs and validations

Job description

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