Packaging Engineer: GMP-Driven Process Optimizer

Mentor Technical Group; South Carolina; On-site; USD 85,000 - 120,000; Full time

Job summary

Mentor Technical Group seeks a Packaging Engineer to support, optimize, and implement packaging processes within regulated manufacturing environments. You will provide technical expertise for packaging operations, qualifications, improvements, troubleshooting, and ensuring FDA, GMP, and company quality standards.

You will collaborate with Manufacturing, Quality, Validation, Maintenance, Automation, and Supply Chain to deliver compliant packaging operations.

Qualifications

• Bachelor's or higher in a technical engineering discipline.
• 3+ years in packaging/ manufacturing/ process engineering in regulated environments.
• Experience with pharmaceutical/biotech/medical device packaging operations.
• Hands-on with cartoners, fillers, labelers, case packers, checkweighers, vision systems.
• Strong RCA, CAPA, and process optimization experience.
• Knowledge of GMP, FDA requirements, change control, and validation.
• Strong technical writing and SOP/protocol/report creation skills.
• Ability to manage multiple priorities in a dynamic setting.
• Excellent communication and cross-functional collaboration.

Responsibilities

• Provide technical support for primary and secondary packaging operations.
• Design and implement packaging processes and equipment improvements.
• Support line qualifications, validations, commissioning, and verifications.
• Conduct RCA investigations for packaging deviations and equipment issues.
• Develop and execute protocols, reports, SOPs, change controls, and docs.
• Evaluate packaging materials for regulatory compliance and efficiency.
• Coordinate equipment installations, upgrades, and startup activities.
• Monitor line performance and drive productivity and quality improvements.
• Support QA and Validation for regulatory audits.
• Ensure GMP, FDA, ISO, and internal standards compliance.
• Assist with serialization, track-and-trace, and packaging automation when applicable.

Skills

Root Cause Analysis

CAPA investigations

Troubleshooting

Cross-functional collaboration

Technical writing

Project management

Process optimization

Regulatory compliance

Problem solving

Communication

Education

Bachelor’s Degree in Mechanical/Industrial/Chemical/Manufacturing/Packaging Engineering

Master’s Degree in Engineering/Packaging Engineering

Tools

Systech

Optel

SAP

TrackWise

Maximo

PLC/HMIs/Vision systems

Job description

Mentor Technical Group seeks a Packaging Engineer to support, optimize, and implement packaging processes within regulated manufacturing environments. You will provide technical expertise for packaging operations, qualifications, improvements, troubleshooting, and ensuring FDA, GMP, and company quality standards.

You will collaborate with Manufacturing, Quality, Validation, Maintenance, Automation, and Supply Chain to deliver compliant packaging operations.