Validation Engineer III - CSV, IQ/OQ, GMP Expert

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 670.000 - 1.004.000; Jornada completa

Descripción de la vacante

BEPC Inc. Mexico is seeking a Validation Engineer III with strong expertise in IQ/OQ execution, CSV, TMV, and pre-validation experimentation.

You will lead complex validation activities, support calibration documentation, and apply statistical and continuous improvement methods in regulated manufacturing environments. The role requires experience in GMP, GDP, and the ability to produce robust completion reports while coordinating with cross-functional teams in the Life Science and Technology

Formación

• Windchill experience is required.
• Strong grasp of statistics at an intermediate level.
• Familiarity with Six Sigma, DMAIC and Kaizen methods.

Responsabilidades

• Provide validation engineering support across IQ/OQ/CSV/TMV protocols.
• Lead pre-validation experiments and contribute to calibration/maintenance records.
• Ensure validation activities comply with GMP and GDP standards and timelines.
• Prepare data for completion reports and validation documentation.

Conocimientos

Presentation skills

Statistics (intermediate)

Six Sigma / DMAIC / Kaizen

English (intermediate)

Educación

Engineering degree

Master's in science (nice-to-have)

Herramientas

Windchill

Descripción del empleo

BEPC Inc. Mexico is seeking a Validation Engineer III with strong expertise in IQ/OQ execution, CSV, TMV, and pre-validation experimentation.

You will lead complex validation activities, support calibration documentation, and apply statistical and continuous improvement methods in regulated manufacturing environments. The role requires experience in GMP, GDP, and the ability to produce robust completion reports while coordinating with cross-functional teams in the Life Science and Technology