Ingeniero de Validacion II

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 360.000 - 540.000; Jornada completa

Descripción de la vacante

BEPC Inc. - Business Excellence Professional Consulting seeks engineers to provide technical support for validations, write IQ and OQ protocols, and supply data for completion reports. You will assist in pre-validation experiments and ensure activities meet GMP standards, GDP practices, and client expectations.

Strong English and presentation skills are needed. Ideal candidates have 2–4 years in manufacturing or 2–3 years in medical industries, with knowledge of basic validation, Six Sigma, and

Formación

• Demonstrates knowledge in basic validation skills and GMP/GDP.
• Experience with validation execution and data handling for reports.
• Intermediate English reading/writing and presentation skills.
• Experience in manufacturing and/or medical industries is preferred.

Responsabilidades

• Provide technical engineering support for validations and write IQ and OQ protocols.
• Provide data to write completion reports for the assigned validations.
• Support execution of experiments during the pre-validation phase.
• Ensure validation activities comply with GMP and current requirements.
• Create forms to document calibration and preventive maintenance records.

Conocimientos

Validation basics

GMP GDP knowledge

IQ/OQ protocols

Statistics

Six Sigma

Documentation

Presentation skills

Descripción del empleo

Provide technical engineering support for validations, write and execute Installation Qualification (IQ) protocols, and provide data to write completion reports for assigned validations.

Provide technical engineering support for validations, write and execute Operational Qualification (OQ) protocols, and provide data to write completion reports for assigned validations.

Support in the execution of experiments during the pre-validation phase.

Ensure that assigned validation activities are performed in a timely manner and in accordance with current requirements and Good Manufacturing Practices (GMP).

Demonstrate sufficient knowledge in basic validation skills, GMP, Good Documentation Practices (GDP).

Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.

2 - 4 years of experience in the manufacturing industry and/or 2 – 3 years of experience in medical industry

Good presentation skills before groups/clients.

Intermediate knowledge of statistics.

Basic knowledge of Six Sigma, DMAIC and Kaizen.

Intermediate English level (reading and writing) with intermediate conversation skills.