Staff CSV Validation Engineer (LIMS) DOE Expert

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 864.000 - 1.056.000; Jornada completa

Descripción de la vacante

BEPC Inc. Mexico, a division of BEPC Incorporated, seeks a Staff Software Validation Engineer (CSV) to drive end-to-end validation strategies across process, equipment, computer systems, and maintenance validations.

You will lead DOE development, Lean Six Sigma initiatives, and project-level execution while collaborating with Operations, Design, and Engineering to ensure regulatory, quality, and design requirements are met.

Formación

• Engineering degree; 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 - should be able to draft, approve Software Validation documents - like URS, Test Protocol, Computer specifications etc.
• Expert with working/collaborating cross functional departments, multiple suppliers.
• Expert with MS Project, Project Management - manage/track action plans for multiple equipment validation
• Good presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE).

Responsabilidades

• Lead and ensure on-time execution of Continuous Improvement Workstream #2 projects.
• Execute and generate moderate to high complex validation documentation.
• Communicate status to DTx Core Team and stakeholders.
• Update project metrics and site dashboards (PO Tracker, Timelines, Validation Documentation Tracker, Risk Register, KPI Tracker).
• Provide training sessions on validation processes and tools.
• Create and submit Change Projects & Change Orders with proper documentation.
• Collaborate to gather requirements/feedback for validation materials.
• Monitor validation activities and report to project lead and leadership.
• Provide technical support for validations and write IQ/OQ/PQ/CSV protocols and completion reports.
• Support development of production of new products.
• Verify product meets regulatory and design requirements.

Conocimientos

Software Validation

DOE

MS Project

Regulatory GMP

LIMS integration

Cross-functional teamwork

Validation documentation

Educación

Engineering Degree

Master’s in Science (plus)

Herramientas

URD/URS templates

IQ/OQ/PQ tools

Descripción del empleo

BEPC Inc. Mexico, a division of BEPC Incorporated, seeks a Staff Software Validation Engineer (CSV) to drive end-to-end validation strategies across process, equipment, computer systems, and maintenance validations.

You will lead DOE development, Lean Six Sigma initiatives, and project-level execution while collaborating with Operations, Design, and Engineering to ensure regulatory, quality, and design requirements are met.