Validation Engineer II

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 450.000 - 600.000; Jornada completa

Descripción de la vacante

BEPC Mexico, a division of BEPC Incorporated, seeks a Validation Engineer II to join our Ciudad Juárez team. You will provide advanced technical support for validation activities, including IQ and OQ protocol development and execution, and assist with pre-validation experiments to ensure GMP compliance in medical device environments.

The role requires 2–4 years in manufacturing or 2–3 years in medical devices, with intermediate English, good presentation skills, and a working knowledge of

Formación

• Experience in manufacturing or medical devices industries.
• Strong presentation skills to client groups.
• Working knowledge of statistics.
• Familiarity with GMP and GDP basics.

Responsabilidades

• Write and execute IQ protocols and provide data for completion reports.
• Write and execute OQ protocols and provide data for completion reports.
• Support the execution of pre-validation experiments.
• Ensure validation activities comply with GMP/GDP requirements.
• Create/calibrate records and forms for calibration and preventive maintenance.

Conocimientos

Presentation skills

Statistics

Six Sigma

DMAIC

Kaizen

English proficiency

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 Mexicoand around the globe.

BEPC Inc. is seeking a Validation Engineer II to join our fast-growing team of consultants in the Ciudad Juárez area. This role provides advanced technical engineering support for validation activities, including the development and execution of IQ and OQ protocols, support during pre-validation experiments, and preparation of validation completion reports. The position plays a key role in ensuring compliance with GMP, GDP, and current regulatory requirements within manufacturing and 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.
• 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.

MAIN QUALIFICATIONS:

• 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.