Senior Software Validation Engineer - CSV & DOE Expert

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

Descripción de la vacante

BEPC Inc. seeks a Staff Software Validation Engineer (CSV) with deep expertise in end-to-end validation strategies, including process, equipment, computer systems and maintenance validations.

This role leads DOE development, Lean Six Sigma initiatives, and project execution while collaborating with Operations, Design and Engineering to ensure products meet regulatory, quality and design requirements. Responsibilities include leading validation documentation, IQ/OQ/PQ/CSV protocols, change

Formación

• Engineering degree; master's in science is a plus.
• 6–9 years of experience in medical industry.
• Expert with LIMS or linking equipment to LIMS software.
• Expert in Software Validation; able to draft/approve URS, Test Protocols, etc.
• Experience collaborating across cross-functional departments and multiple suppliers.
• Proficient in MS Project and project management; manage multiple validations.
• Strong presentation skills for groups/clients.
• Solid experience in DOE (factorial experiments).
• Bilingual.

Responsabilidades

• Lead and ensure on-time execution of Continuous Improvement Workstream #2 projects.
• Execute and generate moderate to high complexity validation documentation.
• Communicate activities to DTx Core Team, site leadership, and stakeholders.
• Update project metrics, weekly updates, and dashboards.
• Provide training sessions on validation processes and tools.
• Create and submit Change Projects & Change Orders with proper documentation.
• Collaborate to gather requirements and feedback for validation docs and training materials.
• Monitor status of validation activities and Change Orders.
• Provide engineering support for IQ protocols and data to completion reports.
• Provide engineering support for OQ and PQ protocols and reports.
• Provide engineering support for CSV protocols.
• Run pre-validation experiments and other experiments as needed.
• Ensure validation activities comply with GMP and GDP.
• Execute validation and create calibration/maintenance records.
• Support development of production of new products.
• Analyze/manufacturing functions and facilities to produce the client's product.
• Verify regulatory and design requirements with Operations and Design teams.

Conocimientos

LIMS integration

Software Validation

DOE

Cross-functional collaboration

Documentation writing

Presentation skills

Educación

Engineering Degree

Master’s in Science (plus)

Herramientas

MS Project

LIMS software tools

Descripción del empleo

BEPC Inc. seeks a Staff Software Validation Engineer (CSV) with deep expertise in end-to-end validation strategies, including process, equipment, computer systems and maintenance validations.

This role leads DOE development, Lean Six Sigma initiatives, and project execution while collaborating with Operations, Design and Engineering to ensure products meet regulatory, quality and design requirements. Responsibilities include leading validation documentation, IQ/OQ/PQ/CSV protocols, change