05 ago
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BEPC Inc. - Business Excellence Professional Consulting
|
Chihuahua
05 ago
BEPC Inc. - Business Excellence Professional Consulting
Chihuahua
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.
At BEPC Inc., we are looking for a Staff Validation Engineer with deep expertise in end-to-end validation strategies, including process, equipment, computer systems, and maintenance validations.
This role will lead DOE development, Lean Six Sigma initiatives, and project-level execution, while collaborating closely with Operations, Design, and Engineering teams to ensure products meet regulatory, quality, and design requirements.
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 Performance Qualification (PQ) 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.
- Provide technical engineering support for validations, write, and execute SAT (Factory Acceptance Testing) validation protocols, and provide data to write completion reports for assigned validations.
- Responsible for running experiments during the pre-validation phase, running 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.
- Support for the development of the production of new products.
- Responsible for the analysis and development of manufacturing functions, capabilities and facilities necessary to produce the client's product.
- Work with the Operations and Design team to verify and validate that the product under development meets regulatory and design requirements.
MAIN QUALIFICATIONS:
- Engineering Degree (master's in science is a plus)
- 7 - 10 years of experience in manufacturing industry and/or 6 – 9 years of experience in medical industry
- Good presentation skills before groups/clients.
- Solid skills in developing Factorial Experiments (DOE).
- Strong knowledge in Lean Six Sigma, DMAIC and Kaizen.
- Strong knowledge in Project Management.
- Extensive knowledge of statistics.
📌 Staff Validation Engineer (Chihuahua)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Chihuahua