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.
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 Test Method 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.
BASIC qualifications
- Engineering Degree (master’s in science is a plus).
- 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.
- Advanced English proficiency
- Experience in validation activities and product knowledge of the following medical devices (MUST):
- OCTARAY Mapping Catheter
- THERMOCOOL SMARTTOUCH SF (STSF - Surround Flow) Catheter
- QDOT MICRO Catheter
- Valid U.S. tourist visa and availability to travel (REQUIRED).
MXOPS
Pay: $100.00 - $200.00 per hour
Work Location: In person
📌 Validation Engineer Iii (Ciudad Juárez)
🏢 Bepc
📍 Ciudad Juárez
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