Packaging Engineer: cGMP & Validation Specialist

Mentor Technical Group; South Carolina; On-site; USD 85,000 - 115,000; Full time

Job summary

Mentor Technical Group is seeking a Packaging Engineer to lead design, development, qualification, and implementation of packaging for pharma/regulatory products. You will review specifications, validate packaging systems, and work with suppliers while ensuring cGMP compliance and continuous improvement.

The role requires 3–5 years of experience in regulated packaging, knowledge of ISTA, Lean Six Sigma, and bilingual English/Spanish is preferred.

Qualifications

• Bachelor’s degree in Packaging Engineering, Mechanical, Industrial, Chemical, or related discipline.
• 3–5 years packaging engineering experience in pharmaceutical, biotech, medical device, or regulated manufacturing.
• Strong knowledge of cGMP and regulatory requirements.
• Experience with packaging validation, qualification, and testing activities.
• Knowledge of packaging materials, labeling, and automated equipment.
• Experience with Change Control, CAPA, Deviations, Risk Assessments, and CI.
• ISTA familiarity is preferred.
• Bilingual English/Spanish preferred.

Responsibilities

• Coordinate packaging-related engineering and validation activities.
• Ensure packaging processes meet quality and regulatory requirements.
• Troubleshoot and resolve packaging-related issues.
• Evaluate and implement packaging process improvements.
• Facilitate communication across Engineering, Manufacturing, Quality, Supply Chain, and suppliers.
• Monitor packaging performance metrics and recommend optimizations.
• Support project execution, timelines, and deliverables for packaging systems.
• Ensure documentation accuracy and compliance with procedures and standards.

Skills

cGMP knowledge

CAPA

Risk assessments

Regulatory compliance

Project management

Lean Six Sigma

Bilingual English/Spanish

Education

Bachelor’s degree in Packaging Engineering / related discipline

Tools

ISTA

MS Office

Job description

Mentor Technical Group is seeking a Packaging Engineer to lead design, development, qualification, and implementation of packaging for pharma/regulatory products. You will review specifications, validate packaging systems, and work with suppliers while ensuring cGMP compliance and continuous improvement.

The role requires 3–5 years of experience in regulated packaging, knowledge of ISTA, Lean Six Sigma, and bilingual English/Spanish is preferred.