Senior Software Validation Engineer: CSV, DOE & GMP Lead

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

BEPC Inc. is seeking a Staff Software Validation Engineer (CSV) in Mexico to lead end-to-end validation efforts across processes, equipment, computer systems and maintenance.

You will drive DOE development, Lean Six Sigma initiatives, and work closely with Operations, Design, and Engineering to ensure regulatory and quality compliance. The role requires expertise in IQ/OQ/PQ, CSV protocols, GMP/GDP practices, and strong cross-functional collaboration to deliver validated systems and

Formación

• Engineering degree required; master’s is a plus.
• 6–9 years of experience in medical industry.
• Expert with LIMs or linking equipment to LIMs software.
• Expert with Software Validation; able to draft/approve validation docs.
• Experience collaborating with cross-functional departments and multiple suppliers.
• Proficient in MS Project and project management; able to manage/track validation actions.

Responsabilidades

• Lead and ensure on-time execution of Continuous Improvement Workstream #2 projects.
• Develop and generate moderate to high complex validation documentation.
• Communicate updates to Core Team, site leadership, and stakeholders.
• Maintain project metrics, dashboards, timelines, and validation trackers.
• Provide training on validation processes and tools to team members.

Conocimientos

LIMS integration

Software Validation

DOE

GMP/GDP

Project Management

IQ/OQ/PQ

Cross-functional collaboration

Lean Six Sigma

Change management

Educación

Engineering Degree

Master’s degree preferred

Herramientas

MS Project

Descripción del empleo

BEPC Inc. is seeking a Staff Software Validation Engineer (CSV) in Mexico to lead end-to-end validation efforts across processes, equipment, computer systems and maintenance.

You will drive DOE development, Lean Six Sigma initiatives, and work closely with Operations, Design, and Engineering to ensure regulatory and quality compliance. The role requires expertise in IQ/OQ/PQ, CSV protocols, GMP/GDP practices, and strong cross-functional collaboration to deliver validated systems and