BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

We are seeking a
Validation Engineer III – Quality
to execute and support validation activities within regulated medical device manufacturing environments. This role will support process, equipment, test method, and computerized system validations, including the development and execution of IQ/OQ/PQ protocols, Computer Systems Validation (CSV), and Test Method Validation (TMV) activities. The Validation Engineer III will work cross-functionally with Engineering, Manufacturing, Quality, R&D;, and Regulatory teams to ensure validation activities comply with FDA regulations, ISO 13485, GMP, GDP, and internal Quality Management System (QMS) requirements.

KEY RESPONSIBILITIES:

• Execute and support validation activities for manufacturing processes, equipment,



test methods, and computerized systems.

• Write, review, and execute:

o Installation Qualification (IQ)

o Operational Qualification (OQ)

o Performance Qualification (PQ)

o Computer Systems Validation (CSV)

o Test Method Validation (TMV)

o Factory Acceptance Testing (FAT)

o Site Acceptance Testing (SAT)

• Support the maintenance and execution of validation activities associated with the Master Validation Plan (MVP), Master Validation Index (MVI), and Site Validation Master Plan (SVMP).

• Develop validation protocols, reports, forms, and supporting technical documentation in accordance with FDA, ISO 13485, GMP, GDP, and QMS requirements.

• Support the design and execution of Design of Experiments (DOE) and statistical analysis for validation activities.

• Participate in pre-validation activities, including risk assessments, feasibility studies, and experimental runs.

• Coordinat

📌 Quality Engineer III (México)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 México