Packaging Specialist

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

Responsibilities: 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 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 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.

Required Qualifications: 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 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 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 to manage multiple priorities, projects, and deadlines in a dynamic manufacturing environment. Strong communication and cross-functional collaboration skills.

Preferred Qualifications: Master's Degree in Engineering, Packaging Engineering, or a related field. Experience with serialization and aggregation systems such as Systech, Optel, or similar technologies. Knowledge of Track & Trace regulations and packaging compliance requirements. Experience supporting automated packaging lines and OEM packaging equipment. Familiarity with PLCs, HMIs, vision inspection systems, and packaging automation technologies. Lean Manufacturing, Six Sigma Green Belt, or equivalent with enterprise systems such as SAP, TrackWise, Maximo, or equivalent 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.