Lead Packaging & Serialization Engineer

Adare Pharma Solutions; Philadelphia (Philadelphia County); On-site; USD 100,000 - 150,000; Full time

Job summary

Adare Pharma Solutions in Philadelphia is hiring a Senior Packaging Engineer to own packaging system development, validation, and serialization lifecycle management. You will lead technical initiatives, mentor teams, and collaborate with Quality, Manufacturing, Validation, Regulatory, IT, and external partners to deliver compliant packaging solutions.

The role emphasizes risk-based problem solving, process optimization, and adherence to DSCSA, EU FMD, and market requirements while driving

Qualifications

• Bachelor's degree in engineering or a related technical field.
• 6+ years in Packaging Engineering within GMP environments.
• Experience with serialization systems and regulatory compliance.
• Blister packaging experience is a plus.

Responsibilities

• Evaluate, develop, and maintain packaging materials and serialization solutions.
• Serve as site technical expert for packaging equipment and interfaces.
• Lead packaging development for new product introductions and line changes.
• Collaborate with Quality, Manufacturing, Validation, Regulatory, IT, and suppliers.
• Develop packaging studies, trials, protocols, and technical reports.
• Support component and equipment selection for packaging systems.
• Troubleshoot packaging equipment to minimize disruptions and ensure compliance.
• Investigate deviations using root-cause methods and CAPA.
• Lead investigations into packaging defects, vision failures, barcode quality.
• Establish CPPs, CQAs, and control strategies for packaging processes.
• Participate in FMEA, risk assessments, and process validation activities.
• Ensure serialization system lifecycle management including IQ/OQ/PQ.
• Assist in feasibility studies, scale-up, and technical report generation.
• Maintain compliance with DSCSA, EU FMD, and market requirements.
• Author and approve SOPs and validation documentation.

Skills

Packaging Engineering

Serialization systems

Root-cause analysis

Project management

Lean manufacturing

GMP knowledge

Education

Bachelor's degree in Engineering or related technical field

Tools

Serialization systems

Job description

Adare Pharma Solutions in Philadelphia is hiring a Senior Packaging Engineer to own packaging system development, validation, and serialization lifecycle management. You will lead technical initiatives, mentor teams, and collaborate with Quality, Manufacturing, Validation, Regulatory, IT, and external partners to deliver compliant packaging solutions.

The role emphasizes risk-based problem solving, process optimization, and adherence to DSCSA, EU FMD, and market requirements while driving