Packaging Engineer

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 ensures compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

The Packaging Engineer will be responsible for:

• Lead packaging design, development, qualification, and implementation activities for new and existing products.
• Develop, review, and approve packaging specifications, standards, and technical documentation.
• Execute packaging validation and qualification protocols, including IQ, OQ, and PQ activities.
• Evaluate packaging materials, components, suppliers, and packaging system performance.
• Support packaging line improvements to increase efficiency, reduce waste, and optimize costs.
• Conduct packaging risk assessments and identify opportunities for continuous improvement.
• Ensure packaging systems comply with cGMP, regulatory, and customer requirements.
• Investigate packaging-related deviations, complaints, and nonconformances.
• Participate in Change Control activities related to packaging processes, materials, and equipment.
• Collaborate with Manufacturing, Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs teams.
• Analyze packaging performance data and recommend corrective and preventive actions (CAPA).
• Provide technical support during audits, inspections, and regulatory assessments.
• Support technology transfers and new product introduction projects.
• Prepare technical reports, validation summaries, protocols, and presentations.

Key Responsibilities:

The Packaging Engineer will serve as the primary technical resource for packaging systems and will:

• Coordinate packaging-related engineering and validation activities.
• Ensure packaging processes consistently meet quality and regulatory requirements.
• Support troubleshooting and resolution of packaging-related issues.
• Evaluate and implement packaging process improvements.
• Facilitate communication between Engineering, Manufacturing, Quality, Supply Chain, and external suppliers.
• Monitor packaging performance metrics and recommend optimization initiatives.
• Support project execution, timelines, and deliverables related to packaging systems.
• Ensure documentation accuracy and compliance with internal procedures and regulatory standards.

Qualifications / Requirements / Knowledge / Skills:

• Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Chemical Engineering, or a related technical discipline.
• Minimum of 3-5 years of experience in Packaging Engineering within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.
• Strong knowledge of current Good Manufacturing Practices (cGMP) and applicable regulatory requirements.
• Experience with packaging validation, qualification, and testing activities.
• Knowledge of packaging materials, labeling systems, and automated packaging equipment.
• Experience with Change Control, CAPA, Deviations, Risk Assessments, and Continuous Improvement initiatives.
• Familiarity with transportation and distribution testing standards such as ISTA is preferred.
• Excellent skills in reviewing, auditing, and preparing technical documentation.
• Ability to manage multiple projects and prioritize tasks effectively.
• Strong analytical, problem-solving, organizational, and communication skills.
• Proficiency in MS Office applications (Word, Excel, PowerPoint, etc.).
• Experience with Lean Manufacturing and Six Sigma methodologies is preferred.
• Bilingual: fluent in English and Spanish preferred.

Preferred Qualifications:

• Experience supporting packaging operations in FDA-regulated environments.
• Familiarity with serialization, labeling compliance, and packaging artwork processes.
• Lean Six Sigma Green Belt or similar certification preferred.
• Experience with packaging equipment qualification and process optimization.
• Knowledge of supply chain and logistics considerations related to packaging systems.