Lead Software Validation Engineer – CSV & DOE Expert

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 700.000 - 900.000; Jornada completa

Descripción de la vacante

BEPC Inc. Mexico is seeking a Staff Software Validation Engineer (CSV) to lead end-to-end validation strategies for process, equipment, and computer systems. You will drive DOE development, Lean Six Sigma initiatives, and cross-functional collaboration to ensure regulatory and design requirements are met.

The role requires strong expertise in GMP, GDP, and validation documentation, with hands-on IQ/OQ/PQ/CSV execution and change control processes.

Formación

• Engineering degree required; master’s is a plus.
• 6–9 years of experience in medical industry.
• Expert with LIMs software integration and validation.
• Expert in Software Validation with URS, Test Protocols, specs.

Responsabilidades

• Lead and ensure on-time execution of validation projects.
• Create and review validation documentation (IQ/OQ/PQ/CSV).
• Coordinate with DTx Core Team, site leadership, and stakeholders.
• Track project metrics, timelines, and validation trackers.
• Provide training on validation processes and tools.
• Prepare Change Projects and Change Orders with proper approvals.
• Gather requirements and feedback for validation of documentation.

Conocimientos

LIMS software

Software Validation

Project Management

DOE

MS Project

Cross-functional collaboration

Validation documentation

Educación

Engineering Degree

Herramientas

MS Project

Descripción del empleo

BEPC Inc. Mexico is seeking a Staff Software Validation Engineer (CSV) to lead end-to-end validation strategies for process, equipment, and computer systems. You will drive DOE development, Lean Six Sigma initiatives, and cross-functional collaboration to ensure regulatory and design requirements are met.

The role requires strong expertise in GMP, GDP, and validation documentation, with hands-on IQ/OQ/PQ/CSV execution and change control processes.