Software Validation Engineer (LIMS-Windchill)

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 Lab Vantage 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 Lab Vantage 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)

MUSTPREFERRED QUALIFICATIONS: Experience with Lab Vantage 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.