Sterilization/Autoclave Validation Specialist

Mentor Technical Group; Austin (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Mentor Technical Group is seeking a Validation Engineer – Serialization to lead the validation and qualification of serialization and aggregation systems in pharmaceutical manufacturing. You will ensure regulatory compliance while supporting implementation, maintenance, and optimization of serialization processes and equipment.

Key responsibilities include developing IQ/OQ/PQ protocols, coordinating validation activities, and collaborating with Quality, Engineering, Operations and IT to drive

Qualifications

• Bachelor's degree in a technical field (Engineering, Pharmaceutical Sciences, Computer Systems, Biotechnology) required.
• 3–5 years of experience in pharmaceutical manufacturing environments.
• Experience validating serialization and aggregation systems.
• Strong knowledge of FDA 21 CFR Part 11, Annex 11, Data Integrity, GMP, DSCSA, and serialization regulations.
• Experience with IQ/OQ/PQ validation lifecycle.
• Knowledge of packaging equipment, vision systems, printers, scanners, and serialization hardware.
• Exposure to serialization platforms such as SAP ATTP, TraceLink, Systech, Antares Vision, or Optel.
• Familiarity with Change Control, Deviations, CAPA, and Risk Management processes.
• Excellent technical writing and documentation skills.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced project environment.
• Proficiency with Microsoft Office applications.
• Bilingual English and Spanish preferred.
• Strong communication skills for cross-functional teams.

Responsibilities

• Lead validation activities for serialization and aggregation systems.
• Develop, execute, and review IQ, OQ, PQ, FAT, and SAT protocols.
• Support implementation and lifecycle management of serialization equipment and software.
• Ensure compliance with FDA, EU FMD, DSCSA and GMP regulations.
• Perform risk assessments and impact evaluations for serialization processes.
• Review validation documentation, test reports, deviations and change controls.
• Participate in investigations and root cause analysis for serialization.
• Support integration between packaging equipment and serialization systems.
• Collaborate with Quality, Engineering, Manufacturing, IT, and Packaging.
• Assist in audits and regulatory inspections.
• Prepare technical reports and management presentations.

Skills

Serialization systems

Regulatory compliance

QA documentation

Risk assessment

Cross-functional collaboration

Troubleshooting

Microsoft Office

Bilingual English/Spanish (preferred)

Education

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

Tools

SAP ATTP

TraceLink

Systech

Antares Vision

Optel

Job description

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 ensures 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.

Position Overview

The Validation Engineer – Serialization will be responsible for the validation and qualification of serialization and aggregation systems within pharmaceutical manufacturing operations. This role will ensure compliance with current regulatory requirements and corporate quality standards while supporting the implementation, maintenance, and optimization of serialization processes and equipment.

Responsibilities

• Lead validation activities associated with serialization and aggregation systems.
• Develop, execute, and review IQ, OQ, PQ, FAT, and SAT protocols.
• Support implementation and lifecycle management of serialization equipment and software platforms.
• Ensure compliance with FDA, EU FMD, DSCSA, and applicable GMP regulations.
• Perform risk assessments and impact evaluations for serialization processes and systems.
• Review and approve validation documentation, test reports, deviations, and change controls.
• Participate in investigations and root cause analysis related to serialization processes.
• Support integration between packaging equipment, vision systems, Level 2, Level 3, and Level 4 serialization systems.
• Collaborate with Quality, Engineering, Manufacturing, IT, Automation, and Packaging departments.
• Support audit readiness efforts and regulatory inspections.
• Assist in troubleshooting serialization and aggregation equipment issues.
• Monitor validation deliverables and project timelines.
• Prepare technical reports and management presentations.

Key Responsibilities

• Coordinate serialization validation projects from initiation through completion.
• Ensure compliance with regulatory and corporate validation standards.
• Review and approve protocol execution and associated documentation.
• Evaluate changes impacting serialization systems and packaging processes.
• Support deviation investigations and CAPA implementation.
• Provide technical guidance to project teams and stakeholders.
• Facilitate communication among Engineering, Quality Assurance, Operations, Packaging, and IT groups.
• Ensure data integrity requirements are adequately addressed throughout system validation activities.

Qualifications / Requirements / Knowledge / Skills

• Bachelor's degree in Engineering, Pharmaceutical Sciences, Computer Systems, Biotechnology, or a related technical field.
• Minimum of 3-5 years of experience in pharmaceutical manufacturing environments.
• Demonstrated experience in serialization and aggregation systems validation.
• Strong knowledge of FDA 21 CFR Part 11, Annex 11, Data Integrity, GMP, DSCSA, and serialization regulations.
• Experience with validation lifecycle methodology, including IQ/OQ/PQ execution.
• Familiarity with packaging equipment, vision inspection systems, printers, scanners, and serialization hardware.
• Experience with serialization platforms such as SAP ATTP, TraceLink, Systech, Antares Vision, Optel, or similar technologies.
• Working knowledge of Change Control, Deviations, CAPA, and Risk Management processes.
• Excellent technical writing and documentation skills.
• Strong analytical, troubleshooting, and problem-solving abilities.
• Ability to manage multiple priorities in a fast-paced project environment.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Project).
• Bilingual (English and Spanish) preferred.
• Strong verbal and written communication skills with the ability to work effectively in cross-functional teams.

Preferred Qualifications

• Experience supporting serialization projects within packaging operations.
• Knowledge of GAMP 5 validation principles.
• Experience with MES, ERP, and Track & Trace integrations.
• Previous participation in FDA or regulatory inspections.
• PMP, CQV, or equivalent certification is a plus.

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.