Packaging Specialist

About Company

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, MTG serves life sciences clients in six global markets:
United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

The Packaging Engineer is responsible for supporting, optimizing, and implementing packaging processes and systems within regulated manufacturing environments. This role provides technical expertise for packaging operations, equipment qualification, process improvements, troubleshooting activities, and compliance initiatives while ensuring adherence to FDA, GMP, and company quality requirements. The Packaging Engineer works closely with cross-functional teams including Manufacturing, Quality, Validation, Maintenance, Automation, and Supply Chain to ensure efficient, reliable, and compliant packaging operations.

• 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.

• Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Manufacturing Engineering, Packaging Engineering, or a related technical discipline.
• Minimum of three (3) years of experience in packaging engineering, manufacturing engineering, process engineering, or a related role within a regulated industry.
• Experience supporting pharmaceutical, biotechnology, medical device, or consumer healthcare 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 and packaging environments.
• Experience conducting Root Cause Analysis (RCA), CAPA investigations, and process optimization initiatives.
• Working knowledge of GMP regulations, FDA requirements, change control processes, and validation methodologies.
• Strong technical writing skills, including preparation of SOPs, protocols, reports, engineering assessments, and change control…