Staff Software Validation Engineer – CSV & Validation Leader

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 600.000 - 900.000; Jornada completa

Descripción de la vacante

BEPC Mexico, a division of BEPC Incorporated, seeks a Staff Software Validation Engineer (CSV) to lead end-to-end validation strategies across processes, equipment, and computer systems. You will drive DOE development and Lean Six Sigma initiatives while collaborating with Operations, Design, and Engineering teams to ensure regulatory and quality requirements are met.

The role requires 6–9 years in the medical industry, an Engineering degree, andexpertise in Software Validation and LIMS

Formación

• Engineering degree required; master’s in science a plus.
• 6–9 years of experience in medical industry.
• Expert with LIMS or connecting equipment to LIMS software.
• Expert with Software Validation and drafting Validation documents (URS, Test Protocols, etc.).
• Experience collaborating with cross-functional departments and multiple suppliers.
• Proficient in MS Project and project management to track validation actions.
• Strong presentation skills for client meetings.

Responsabilidades

• Lead validation projects and ensure on-time execution per plan.
• Generate and review complex validation documentation (IQ/OQ/PQ/CSV).
• Coordinate with DTx Core Team and site leadership on validation activities.
• Maintain project metrics, dashboards, and risk registers.
• Provide training on validation processes and tools to team members.

Conocimientos

Software Validation

LIMS integration

MS Project

Cross-functional collaboration

Educación

Engineering Degree

Master’s in science

Herramientas

LIMS software

MS Project

Descripción del empleo

BEPC Mexico, a division of BEPC Incorporated, seeks a Staff Software Validation Engineer (CSV) to lead end-to-end validation strategies across processes, equipment, and computer systems. You will drive DOE development and Lean Six Sigma initiatives while collaborating with Operations, Design, and Engineering teams to ensure regulatory and quality requirements are met.

The role requires 6–9 years in the medical industry, an Engineering degree, andexpertise in Software Validation and LIMS