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 productsDevelop, review, and approve packaging specifications, standards, and technical documentationExecute packaging validation and qualification protocols, including IQ, OQ, and PQ activitiesEvaluate packaging materials, components, suppliers, and packaging system performanceSupport packaging line improvements to increase efficiency, reduce waste, and optimize costsConduct packaging risk assessments and identify opportunities for continuous improvementEnsure packaging systems comply with cGMP, regulatory, and customer requirementsInvestigate packaging-related deviations, complaints, and nonconformancesParticipate in Change Control activities related to packaging processes, materials, and equipmentCollaborate with Manufacturing, Quality, Supply Chain, Operations, Engineering, and Regulatory Affairs teamsAnalyze packaging performance data and recommend corrective and preventive actions (CAPA)Provide technical support during audits, inspections, and regulatory assessmentsSupport technology transfers and new product introduction projectsPrepare 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 activitiesEnsure packaging processes consistently meet quality and regulatory requirementsSupport troubleshooting and resolution of packaging-related issuesEvaluate and implement packaging process improvementsFacilitate communication between Engineering, Manufacturing, Quality, Supply Chain, and external suppliersMonitor packaging performance metrics and recommend optimization initiativesSupport project execution, timelines, and deliverables related to packaging systemsEnsure 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 disciplineMinimum of 3-5 years of experience in Packaging Engineering within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industryStrong knowledge of current Good Manufacturing Practices (cGMP) and applicable regulatory requirementsExperience with packaging validation, qualification, and testing activitiesKnowledge of packaging materials, labeling systems, and automated packaging equipmentExperience with Change Control, CAPA, Deviations, Risk Assessments, and Continuous Improvement initiativesFamiliarity with transportation and distribution testing standards such as ISTA is preferredExcellent skills in reviewing, auditing, and preparing technical documentationAbility to manage multiple projects and prioritize tasks effectivelyStrong analytical, problem-solving, organizational, and communication skillsProficiency in MS Office applications (Word, Excel, PowerPoint, etc.)Experience with Lean Manufacturing and Six Sigma methodologies is preferredBilingual: fluent in English and Spanish preferred Preferred Qualifications: Experience supporting packaging operations in FDA-regulated environmentsFamiliarity with serialization, labeling compliance, and packaging artwork processesLean Six Sigma Green Belt or similar certification preferredExperience with packaging equipment qualification and process optimizationKnowledge of supply chain and logistics considerations related to packaging systems Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley. Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. Powered by JazzHR ReI7T1IlN9