Validation Engineer

Mentor Technical Group; Juncos (PR); In loco; USD 90.000 - 140.000; Tempo pieno

Descrizione del lavoro

Mentor Technical Group (MTG) is seeking an experienced serialization validation professional to support FDA-regulated manufacturing in Puerto Rico and beyond. You will collaborate across Engineering, Quality, Packaging, Automation, and IT to implement serialization platforms and ensure compliant documentation.

The role involves developing and reviewing IQ/OQ/PQ, FAT/SAT, commissioning and validation activities, coordinating with vendors and consultants, managing Change Controls, Deviations,

Competenze

• Bachelor's or master's degree in engineering or related scientific field.
• Minimum two years' experience in GMP-regulated pharma manufacturing or serialization.
• Experience with serialization/aggregation systems preferred.
• Strong knowledge of cGMP, FDA requirements, 21 CFR Part 11, Data Integrity, DSCSA, EU FMD.
• Experience developing, executing IQ/OQ/PQ validation documents.
• Familiarity with serialization platforms such as SAP ATTP, TraceLink, Systech, Optel or equivalents.
• Knowledge of Change Control, CAPA, Deviation Management, and Risk Assessment.
• Proficiency in English; bilingual English/Spanish preferred.

Mansioni

• Collaborate with engineering, quality, packaging, automation and IT to develop serialization procedures and docs.
• Develop, review, execute, and approve IQ/OQ/PQ, FAT, SAT protocols and reports for serialization/track-and-trace.
• Execute commissioning, qualification, and validation activities for serialization equipment and packaging lines.
• Support implementation, configuration, and lifecycle management of serialization hardware/software.
• Coordinate with consultants, integrators, vendors and stakeholders to ensure timely docs and protocol execution.
• Manage change controls, deviations, CAPAs, and risk assessments for serialization systems.
• Ensure compliance with cGMP, FDA 21 CFR Part 11, DSCSA, EU FMD, and DSCSA.
• Provide troubleshooting for serialization equipment, vision systems, printers, scanners, software.
• Participate in root cause investigations and CAPA implementation.
• Support audit readiness and regulatory inspections.
• Transfer knowledge and train on serialization systems and validation methodologies.

Conoscenze

Analytical skills

Problem solving

Technical writing

Communication skills

Cross-functional collaboration

Formazione

Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Computer Systems, or related field

Strumenti

SAP ATTP

TraceLink

Systech

Optel

Antares Vision

Microsoft Office

Descrizione del lavoro

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).

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.