Software Validation Engineer (LIMS-Windchill)

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.

We are seeking an experienced Software Validation Engineer (LIMS-Windchill) to support Windchill change management and LabVantage LIMS implementation within a regulated environment. This role will collaborate with Quality, Laboratory, Manufacturing, and IT teams to support system validation, change control, integration, and compliance with GMP, FDA 21 CFR Part 11, and GAMP 5 requirements.

KEY RESPONSIBILITIES:

• Administer and support Windchill change management processes, including Change Requests (CR), Change Notices (CN), Change Tasks, approvals, workflows, document control, and lifecycle management.
• Support LabVantage LIMS implementation.
• Perform impact assessments and coordinate system changes across Quality, Laboratory, Manufacturing, and IT teams.
• Support system validation activities, including requirements, risk assessments, traceability, and validation documentation.
• Ensure compliance with data integrity, audit trail, electronic records, and electronic signature requirements.
• Investigate system issues, troubleshoot configuration problems, and implement corrective actions.
• Support integration of discussions between LIMS, ERP, PLM, instruments, and other enterprise systems.
• Develop and maintain SOPs, work instructions, and system governance documentation.

REQUIERED QUALIFICATIONS:

• Strong Experience with Windchill change management, document control, and product lifecycle processes.
• Experience using, administering or configuring LabVantage LIMS or a similar regulated LIMS platform.
• Knowledge of GMP, FDA 21 CFR Part 11, GAMP 5, and computerized system validation practices.
• Experience with workflow configuration, security administration, system testing, and change control processes.
• Strong analytical, troubleshooting, and stakeholder management skills.
• The selected candidate must be available to travel to the company’s facilities in Ciudad Juárez on an occasional basis, as needed.
• Bilingual (English/Spanish) MUST

PREFERRED QUALIFICATIONS:

• Experience with LabVantage flows, calculations, and integrations.
• Experience supporting engineering and laboratory systems in regulated pharmaceutical, medical device, or life sciences environments.
• Familiarity with SQL, SAP, ETQ, Empower, Maximo, or other enterprise applications.
• Experience leading validation and deployment activities for global system implementations.