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.

• 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.

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.

• 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…