BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500companies 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 Software Validation Engineer (CSV) 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 designrequirements.

KEY RESPONSIBILITIES:

- Responsible for leading and ensuring on-time execution of Continuous Improvement Workstream #2 active projects as per commitment and plan.
- Execute and generate moderate to high complex validation documentation.
- Responsible for communicating and keeping track of the activities at the DTx Core Team, site leadership, business leadership stakeholders.
- Responsible of updating and keeping track of the project's metrics, weekly updates and site dashboards (PO Tracker, Project Timelines, Validation Documentation Tracker, Risk Register and KPI Tracker).
- Provide training sessions for team members and stakeholders on validation processes and tools.
- Create and submit Change Projects & Change Orders (COs) ensuring proper documentation and approval processes are followed.
- Collaborate with team members to gather requirements and feedback for validation of documentation and training materials.
- Monitor and report on the status of validation activities and Change Orders to the project lead, site leadership and business leadership stakeholders.
- 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.
- 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)
- 6 – 9 years of experience in medical industry
- Expert with LIMs or Expert in connecting equipment's to LIMs software
- Expert with Software Validation - should be able to draft, approve Software Validation documents like URS, Test Protocol, Computer specifications etc.
- Expert with working/collaborating Cross functional departments, multiple suppliers.
- Expert with MS project, Project Management - be able to Manage/track action plans for multiple equipment validation
- Good presentation skills before groups/clients.
- Solid skills in developing Factorial Experiments (DOE).
- Bilingual

📌 Software Validation Engineer (CSV) (Ciudad Juárez)
🏢 BEPC Inc. - Business Excellence Professional Consulting
📍 Ciudad Juárez