Validation Engineer II

BEPC Inc. - Business Excellence Professional Consulting; Ciudad Juárez; Presencial; MXN 300.000 - 420.000; Jornada completa

Descripción de la vacante

BEPC Inc. seeks a Validation Engineer II to join our Ciudad Juárez team, delivering advanced validation support in GMP environments for medical devices and life sciences projects. You will develop and execute IQ and OQ protocols and contribute to validation completion reports.

The role requires hands-on experience in validation activities, strong documentation, and communication with clients. Proficiency in statistics and Six Sigma concepts is valued, with intermediate English skills.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Presentation skills

Statistics

English proficiency

Six Sigma DMAIC Kaizen

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.

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.