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. Position Summary 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. Key Responsibilities Provide technical support for primary and secondary packaging operations within pharmaceutical, biotechnology, and medical device manufacturing environmentsDesign, develop, and implement packaging processes, equipment improvements, and continuous improvement initiativesSupport packaging line qualifications, validations, commissioning, and performance verification activitiesPerform Root Cause Analysis (RCA) investigations related to packaging deviations, equipment failures, process inefficiencies, and product quality issuesDevelop, review, and execute protocols, reports, SOPs, engineering assessments, change controls, and technical documentationEvaluate packaging materials, components, and specifications to ensure product protection, regulatory compliance, and operational efficiencyCoordinate packaging equipment installations, modifications, upgrades, and startup activitiesMonitor packaging line performance and recommend process improvements to increase productivity, reliability, and qualityCollaborate with Quality Assurance and Validation teams to support regulatory audits and inspectionsEnsure compliance with GMP, FDA, ISO, and internal quality standardsSupport serialization, vision inspection systems, label control, track-and-trace systems, and packaging automation technologies when applicableParticipate in risk assessments, CAPA activities, and continuous improvement projects associated with packaging systems and processes Required Qualifications Bachelor’s Degree in Mechanical Engineering, Industrial Engineering, Chemical Engineering, Manufacturing Engineering, Packaging Engineering, or a related technical disciplineMinimum of three (3) years of experience in packaging engineering, manufacturing engineering, process engineering, or a related role within a regulated industryExperience supporting pharmaceutical, biotechnology, medical device, or consumer healthcare packaging operationsHands-on experience with packaging equipment such as cartoners, fillers, labelers, case packers, checkweighers, vision systems, and serialization equipmentStrong troubleshooting and problem-solving skills in manufacturing and packaging environmentsExperience conducting Root Cause Analysis (RCA), CAPA investigations, and process optimization initiativesWorking knowledge of GMP regulations, FDA requirements, change control processes, and validation methodologiesStrong technical writing skills, including preparation of SOPs, protocols, reports, engineering assessments, and change control documentationAbility to manage multiple priorities, projects, and deadlines in a dynamic manufacturing environmentStrong communication and cross-functional collaboration skills Preferred Qualifications Master’s Degree in Engineering, Packaging Engineering, or a related fieldExperience with serialization and aggregation systems such as Systech, Optel, or similar technologiesKnowledge of Track & Trace regulations and packaging compliance requirementsExperience supporting automated packaging lines and OEM packaging equipmentFamiliarity with PLCs, HMIs, vision inspection systems, and packaging automation technologiesLean Manufacturing, Six Sigma Green Belt, or equivalent certificationExperience with enterprise systems such as SAP, TrackWise, Maximo, or equivalent platformsProject Management experience supporting packaging line installations, upgrades, and capital projects 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 lTgcx05tS8