About the role
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, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.
Responsibilities:
* Collaborate with Engineering, Quality, Packaging, Automation, and IT teams to develop and maintain serialization and aggregation validation procedures and documentation. * Develop, review, execute, and approve IQ, OQ, PQ, FAT, and SAT protocols and reports for serialization and track-and-trace systems. * Execute commissioning, qualification, and validation activities for serialization equipment, aggregation systems, and packaging line integrations. * Support the implementation, configuration, and lifecycle management of serialization hardware and software platforms. * Coordinate with external consultants, system integrators, equipment vendors, and internal stakeholders to ensure timely document generation and protocol execution. * Manage Change Controls, Deviations, CAPAs, and risk assessments related to serialization systems and packaging operations. * Ensure compliance with cGMP, FDA regulations, 21 CFR Part 11, Data Integrity, DSCSA, EU FMD, and other applicable serialization requirements. * Support maintenance and calibration activities to improve system reliability, compliance, and operational efficiency. * Provide expertise in troubleshooting serialization equipment, aggregation systems, vision systems, printers, scanners, and software applications. * Participate in root cause investigations and drive implementation of corrective and preventive actions. * Support audit readiness activities and regulatory inspections. * Facilitate the transfer of technical knowledge and provide training on serialization systems, validation methodologies, and regulatory requirements.
Qualifications / Requirements / Knowledge / Education / Skills:
* Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Computer Systems, or a related scientific field. * Minimum of two (2) years of experience in GMP-regulated pharmaceutical manufacturing, commissioning, qualification, validation, or serialization projects. * Experience with serialization and aggregation systems within pharmaceutical packaging operations is preferred. * Strong knowledge of cGMP regulations, FDA requirements, 21 CFR Part 11, Data Integrity, DSCSA, EU FMD, and industry best practices. * Experience developing, executing, and reviewing IQ/OQ/PQ validation documentation. * Familiarity with serialization and track-and-trace platforms such as SAP ATTP, TraceLink, Systech, Optel, Antares Vision, or equivalent technologies. * Knowledge of Change Control, CAPA, Deviation Management, and Risk Assessment processes. * Strong understanding of computerized systems validation (CSV) and GAMP 5 principles is highly desirable. * Proficiency in English; bilingual English and Spanish is preferred. * Excellent analytical, problem-solving, technical writing, and communication skills. * Ability to work collaboratively in a cross-functional team environment. * Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Project).