GMP Packaging Engineer | Serialization & Automation

Mentor Technical Group; Columbia (SC); On-site; USD 75,000 - 105,000; Full time

Job summary

Mentor Technical Group is seeking a Packaging Engineer to support, optimize, and implement packaging processes in regulated manufacturing environments. You will provide technical expertise across packaging operations, equipment qualification, compliance initiatives, and continuous improvement, collaborating with Manufacturing, Quality, Validation, and Automation teams.

You will lead line qualifications, support RCA/CAPA investigations, and ensure adherence to GMP, FDA, and ISO standards while

Qualifications

• Bachelor’s degree in a related technical discipline.
• Minimum of three years of experience in packaging or manufacturing engineering within a regulated industry.
• Experience with pharmaceutical/biotech/medical device packaging operations.
• Hands-on experience with packaging equipment such as cartoners, fillers, labelers, case packers, checkweighers, vision systems, and serialization equipment.
• Strong troubleshooting and problem-solving skills in manufacturing environments.
• Experience with RCA, CAPA, and process optimization.
• Knowledge of GMP, FDA requirements, change control, and validation.
• Strong technical writing skills for SOPs, protocols, reports, engineering assessments, and change control documentation.
• Ability to manage multiple priorities and deadlines in a dynamic manufacturing environment.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Provide technical support for primary and secondary packaging operations within pharmaceutical, biotechnology, and medical device manufacturing environments.
• Design, develop, and implement packaging processes, equipment improvements, and continuous improvement initiatives.
• Support packaging line qualifications, validations, commissioning, and performance verification activities.
• Perform Root Cause Analysis (RCA) investigations related to packaging deviations, equipment failures, process inefficiencies, and product quality issues.
• Develop, review, and execute protocols, reports, SOPs, engineering assessments, change controls, and technical documentation.
• Evaluate packaging materials, components, and specifications to ensure product protection, regulatory compliance, and operational efficiency.
• Coordinate packaging equipment installations, modifications, upgrades, and startup activities.
• Monitor packaging line performance and recommend process improvements to increase productivity, reliability, and quality.
• Collaborate with Quality Assurance and Validation teams to support regulatory audits and inspections.
• Ensure compliance with GMP, FDA, ISO, and internal quality standards.
• Support serialization, vision inspection systems, label control, track-and-trace systems, and packaging automation technologies when applicable.
• Participate in risk assessments, CAPA activities, and continuous improvement projects associated with packaging systems and processes.

Skills

Troubleshooting

Cross-functional collaboration

Regulatory compliance

Process optimization

Education

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

Tools

Cartoners

Fillers

Labelers

Case packers

Checkweighers

Vision systems

Serialization equipment

PLCs/HMIs

Job description

Mentor Technical Group is seeking a Packaging Engineer to support, optimize, and implement packaging processes in regulated manufacturing environments. You will provide technical expertise across packaging operations, equipment qualification, compliance initiatives, and continuous improvement, collaborating with Manufacturing, Quality, Validation, and Automation teams.

You will lead line qualifications, support RCA/CAPA investigations, and ensure adherence to GMP, FDA, and ISO standards while