Validation Engineering

hace 3 días

Juárez Juárez Chih, México BEPC Inc. - Business Excellence Professional Consulting A tiempo completo

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 has a OPEN POSITION for Validation Engineer III to join our fast-growing team of consultants

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 Total Maintenance 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.

QUALIFICATIONS:
• 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 in statistics.
• Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
• Intermediate English level (reading and writing) with intermediate conversation skills.

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