Validation Engineer III

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. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe.

At BEPC Inc., we are looking for a Validation Engineer III with strong expertise in IQ/OQ execution, Computer Systems Validation (CSV), Test Method Validation (TMV), and pre-validation experimentation. This role will lead complex validation activities, support calibration and preventive maintenance documentation, and apply statistical analysis and continuous improvement methodologies (Six Sigma, DMAIC, Kaizen) in regulated manufacturing environments.

KEY RESPONSIBILITIES:

• 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.
• Provide technical engineering support for validations, write and execute Computer Systems Validation (CSV) protocols.
• Provide technical engineering support for validations, write and execute Test Method Validation (TMV) protocols.
• Responsible for running experiments during the pre-validation phase, run other experiments as needed.
• 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 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.

MAIN QUALIFICATIONS

• Demonstrated experience using Windchill
• Engineering Degree (master's in science is a plus)
• 3 - 5 years of experience in the manufacturing industry and/or 3 - 4 years of experience in medical industry
• Good presentation skills before groups/clients.
• Intermediate knowledge of statistics.
• Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
• Intermediate English level (reading and writing) with intermediate conversation skills.