Sr. Validation Engineer (Medical Industry)

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

Descripción de la vacante

BEPC Inc. Mexico seeks a Senior Validation Engineer with deep expertise in process, equipment, and computer systems validation (IQ/OQ/PQ, CSV, TMV, and SAT) to lead validation strategies and DOE executions in regulated medical device environments.

You will drive GMP/GDP practices, run pre-validation experiments, ensure timely completion, and mentor teams, with 4–5 years in medical industry and strong Lean/Six Sigma skills.

Formación

• Engineering degree required; master’s in science is a plus.
• DOE experience is essential.
• Lean methodologies knowledge required.
• Six Sigma knowledge (DMAIC) encouraged.
• Project management experience preferred.
• GMP and GDP awareness required.

Responsabilidades

• Provide technical engineering support for validations across IQ, OQ, PQ, CSV, TMV, and SAT.
• Write and execute validation protocols and contribute data for completion reports.
• Lead validation strategies and design experiments (DOE).
• Ensure validations comply with GMP, GDP, and current regulatory requirements.
• Perform pre-validation experiments and other tests as needed.
• Deliver timely validation activities and maintain accurate documentation.

Conocimientos

DOE development

Lean methodologies

Six Sigma

Project management

Validation

GMP/GDP

Educación

Engineering degree

Master's degree a plus

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 Senior Validation Engineer with deep expertise in process, equipment, and computer systems validation, including IQ/OQ/PQ, CSV, TMV, and SAT. This role will lead validation strategies, execute Design of Experiments (DOE), apply Lean and Six Sigma methodologies, and support validation projects from planning through execution in regulated medical device 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 Performance Qualification (PQ) 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.
• Provide technical engineering support for validations, write, and execute SAT (Site Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.
• 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.

QUALIFICATIONS:

• Engineering Degree (master's in science is a plus)
• 4 - 5 years of experience in medical industry
• Good presentation skills before groups/clients.
• Solid skills in developing Factorial Experiments (DOE's) - Must
• Extensive knowledge in Lean.
• Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
• Intermediate knowledge of Project Management.