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 RESPONSABILITIES**:
- 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 Test Method 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, 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)
- 4 - 5 years of experience in medical industry
- Good presentation skills before groups/clients.
- Solid skills in developing Factorial Experiments (DOE).
- Extensive knowledge in Lean.
- Intermediate knowledge in Six Sigma, DMAIC and Kaizen.
- Intermediate knowledge of Project Management.
- Extensive knowledge of statistics.
- Advanced English proficiency
MXOPS
Sueldo: $100.00 - $200.00 al mes
Incentivos:
- Seguro de gastos médicos mayores
- Seguro dental
Lugar de trabajo: Empleo presencial