Senior Validation Engineer III — CSV, IQ/OQ & Six Sigma

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 420.000 - 660.000; Jornada completa

Descripción de la vacante

BEPC Inc. is seeking a Validation Engineer III with strong expertise in IQ/OQ execution, CSV, TMV, and pre-validation experimentation. The role will lead complex validation activities in regulated manufacturing environments and support GMP documentation and continuous improvement initiatives.

The candidate will apply statistical analysis and Six Sigma/ DMAIC/Kaizen methods to improve validation processes, ensure timely completion, and maintain compliance, with travel as required.

Formación

• Engineering degree; master's in science is a plus.
• 3–4 years in the medical industry.
• Strong presentation skills before groups/clients.
• Intermediate statistics knowledge.
• Intermediate Six Sigma, DMAIC and Kaizen.
• Advanced English proficiency.
• Experience in validation activities and medical devices (MUST).
• Valid U.S. tourist visa and willingness to travel (REQUIRED).

Responsabilidades

• Provide IQ/OQ protocols, write and provide data for completion reports.
• Provide OQ protocols, write and provide data for completion reports.
• Provide CSV protocols and execution data.
• Provide TMV protocols and execution data.
• Run pre-validation experiments as needed.
• Ensure validation activities are performed in a GMP-compliant manner.
• Create forms to document calibration and preventive maintenance records.

Conocimientos

IQ/OQ execution

Computer Systems Validation

TMV

Statistical analysis

Six Sigma

DMAIC

Kaizen

Educación

Engineering Degree

Descripción del empleo

BEPC Inc. is seeking a Validation Engineer III with strong expertise in IQ/OQ execution, CSV, TMV, and pre-validation experimentation. The role will lead complex validation activities in regulated manufacturing environments and support GMP documentation and continuous improvement initiatives.

The candidate will apply statistical analysis and Six Sigma/ DMAIC/Kaizen methods to improve validation processes, ensure timely completion, and maintain compliance, with travel as required.