Serialization Validation Engineer - GMP Systems Impact

Mentor Technical Group; Juncos (PR); On-site; USD 90,000 - 140,000; Full time

Job summary

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,

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical skills

Problem solving

Technical writing

Communication skills

Cross-functional collaboration

Education

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

Tools

SAP ATTP

TraceLink

Systech

Optel

Antares Vision

Microsoft Office

Job description

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,