Validation Engineer II (Medical Industry)

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:

• Develop, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Support validation activities and pre-validation experiments within manufacturing processes.
• Generate validation reports and maintain accurate technical documentation.
• Support in the execution of experiments during the pre-validation phase.
• Utilize Minitab and statistical tools for data analysis and process evaluation.
• 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).
• Support continuous improvement initiatives and process optimization activities.
• Responsible for the execution of validation, including the creation of forms to create calibration and preventive maintenance records.

QUALIFICATIONS:

• Engineering Degree
• 2 - 4 years of experience in the manufacturing industry and/or 2 – 3 years of experience in medical industry
• Knowledge and hands-on experience with IQ, OQ, and PQ validation processes.
• Knowledge of statistical analysis and data interpretation using Minitab.
• Experience performing root cause analysis and validation failure investigations.
• 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.
• Proactive attitude with the ability to work independently and collaboratively.