Senior Packaging & Labeling Quality Engineer
Harba5 months ago
Indianapolis, IN, United States
Hybrid
Full-time
Junior Level (1-3 years)
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
Required Skills
GMP Compliance
Risk Assessments
CAPA Management
Automated Packaging Technologies
Serialization
Pharmaceutical Packaging
SOP Review
Validation Activities
Investigation Management
Continuous Improvement
Quality Assurance
Labeling Operations
Deviation Management
Batch Record Documentation
Audit Readiness
Cross-functional Collaboration