Senior Software Validation Engineer (CSV) – DOE & GMP

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 600.000 - 1.000.000; Jornada completa

Descripción de la vacante

BEPC Inc. Mexico is seeking a Staff Software Validation Engineer (CSV) to lead end-to-end validation across software, equipment, and computer systems in support of life science and automotive projects.

You will drive DOE development, Lean Six Sigma initiatives, and Validation documentation while collaborating with Operations, Design, and Engineering to ensure GMP-compliant products meet regulatory and design requirements.

Formación

• Engineering degree; master’s in science is a plus.
• 6–9 years of experience in medical industry.
• Expert with LIMS or expert in connecting equipment to LIMS software.
• Expert with Software Validation and ability to draft URS, Test Protocols, and computer specifications.
• Expert with cross-functional collaboration across departments and multiple suppliers.
• MS Project and Project Management to manage validation action plans for multiple equipment.
• Strong presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE).

Responsabilidades

• Lead and ensure on-time execution of validation projects.
• Execute and generate moderate to high complex validation documentation.
• Communicate updates to core teams and stakeholders.
• Maintain project metrics, weekly updates, and dashboards.
• Provide training sessions on validation processes and tools.
• Create Change Projects & Change Orders with proper documentation.
• Gather requirements and feedback for validation materials.
• Monitor status of validation activities and report to leadership.
• Support for IQ/OQ/PQ/CSV protocol development and data for completion reports.
• Run pre-validation experiments and other required tests.
• Ensure validation activities comply with GMP and GDP.
• Demonstrate knowledge of validation skills and Good Documentation Practices.
• Assist in development of production of new products.
• Analyze manufacturing functions and facilities to produce client products.
• Work with Operations and Design to verify regulatory and design requirements.

Conocimientos

Cross-functional collaboration

Software validation

DOE (Design of Experiments)

Presentation skills

Validation documentation

Educación

Engineering Degree

Master’s in science (preferred)

Herramientas

LIMS software

MS Project

Descripción del empleo

BEPC Inc. Mexico is seeking a Staff Software Validation Engineer (CSV) to lead end-to-end validation across software, equipment, and computer systems in support of life science and automotive projects.

You will drive DOE development, Lean Six Sigma initiatives, and Validation documentation while collaborating with Operations, Design, and Engineering to ensure GMP-compliant products meet regulatory and design requirements.