Serialization Validation Engineer — Pharma Compliance

Mentor Technical Group; Texas; Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

Mentor Technical Group is seeking a Validation Engineer – Serialization to validate and qualify serialization and aggregation systems within pharmaceutical manufacturing, ensuring compliance with FDA and worldwide regulations.

You will develop IQ/OQ/PQ protocols, support installation and lifecycle management of serialization equipment and software, and collaborate with Quality, Engineering, Manufacturing, IT, and Packaging teams to drive quality and efficiency.

Qualifications

• Bachelor's degree in a technical field such as engineering, pharma sciences, or computer systems.
• 3–5 years in pharmaceutical manufacturing with serialization validation experience.
• Familiarity with FDA 21 CFR Part 11, Annex 11, Data Integrity, GMP, DSCSA, and serialization regulations.

Responsabilités

• Lead validation activities for serialization and aggregation systems.
• Develop, execute, and review IQ, OQ, PQ, FAT, and SAT protocols.
• Support lifecycle management of serialization equipment and software.
• Ensure compliance with FDA, EU FMD, DSCSA, and GMP.
• Perform risk assessments and impact evaluations for serialization processes.
• Review and approve validation documentation and change controls.
• Collaborate with Quality, Engineering, Manufacturing, IT, Automation, and Packaging.

Connaissances

Serialization validation

Regulatory compliance

IQ/OQ/PQ execution

Technical writing

Cross-functional teamwork

Analytical thinking

Project coordination

MS Office

Bilingual English/Spanish

Communication skills

Formation

Bachelor's degree in Engineering

Bachelor's degree in Pharmaceutical Sciences

Bachelor's degree in Computer Systems

Outils

SAP ATTP

TraceLink

Systech

Antares Vision

Optel

Description du poste

Mentor Technical Group is seeking a Validation Engineer – Serialization to validate and qualify serialization and aggregation systems within pharmaceutical manufacturing, ensuring compliance with FDA and worldwide regulations.

You will develop IQ/OQ/PQ protocols, support installation and lifecycle management of serialization equipment and software, and collaborate with Quality, Engineering, Manufacturing, IT, and Packaging teams to drive quality and efficiency.