Packaging Engineer, GMP & Regulated Life Sciences

Mentor Technical Group; United States; On-site; USD 90,000 - 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, equipment qualification, process improvements, troubleshooting activities, and compliance initiatives.

Close collaboration with Manufacturing, Quality, Validation, Maintenance, Automation, and Supply Chain is essential to ensure efficient, reliable packaging operations.

Qualifications

• Bachelor’s degree required in a technical discipline related to packaging
• Minimum of 3 years in packaging/manufacturing/process engineering in a regulated environment
• Experience with pharmaceutical/biotech/medical device packaging operations
• Hands-on with packaging equipment (cartoners, fillers, labelers, case packers, checkweighers, vision, serialization)
• Strong troubleshooting, RCA, CAPA, and process optimization skills
• Familiarity with GMP, FDA requirements, change control, and validation methodologies
• Excellent technical writing skills (SOPs, protocols, reports)
• Ability to manage multiple priorities in a dynamic manufacturing setting
• Strong communication and cross-functional collaboration skills

Responsibilities

• Provide technical support for primary and secondary packaging operations in regulated environments
• Design and implement packaging processes, equipment improvements, and CI initiatives
• Support line qualifications, validations, commissioning, and performance verification activities
• Conduct RCA investigations related to packaging deviations, equipment failures, and process inefficiencies
• Develop and execute protocols, reports, SOPs, and change controls
• Evaluate packaging materials and specifications for product protection and regulatory compliance
• Coordinate packaging equipment installations, modifications, and startup activities
• Monitor line performance and recommend improvements for productivity and quality
• Collaborate with QA and Validation to support regulatory audits and inspections
• Ensure adherence to GMP, FDA, ISO, and internal quality standards
• Assist with serialization and packaging automation technologies when applicable
• Participate in risk assessments, CAPA, and CI projects related to packaging systems

Skills

Packaging engineering expertise

Root Cause Analysis

Regulatory compliance

Cross-functional collaboration

Troubleshooting

Education

Bachelor’s Degree in Mechanical/Industrial/Packaging Engineering

Master’s Degree (preferred)

Tools

Cartoners

Fillers

Labelers

Case packers

Checkweighers

Vision systems

Serialization equipment

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, equipment qualification, process improvements, troubleshooting activities, and compliance initiatives.

Close collaboration with Manufacturing, Quality, Validation, Maintenance, Automation, and Supply Chain is essential to ensure efficient, reliable packaging operations.