Windchill and LIMS System Engineer

BEPC Inc. - Business Excellence Professional Consulting; El Paso (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

BEPC Inc. provides specialized engineering solutions and IT project management with a focus on regulated environments.

The role supports Windchill change management and LabVantage LIMS implementations, coordinating across Quality, Lab, Manufacturing, and IT teams to ensure compliance and system integrity. Ideal candidates will demonstrate expertise in GMP, 21 CFR Part 11, and GAMP 5, plus experience with validation activities, risk assessments, and cross-functional collaboration.

Qualifications

• Windchill change management and document control expertise.
• Experience with LabVantage LIMS or similar regulated LIMS.
• Knowledge of GMP, FDA 21 CFR Part 11, and GAMP 5.
• Experience with workflow configuration, security, testing, and change control.
• Strong analytical, troubleshooting, and stakeholder management skills.
• Willingness to visit Juárez plants.

Responsibilities

• Administer Windchill change management processes, including CRs, CNs, tasks, approvals, workflows, and lifecycle management.
• Support LabVantage LIMS implementation and integration with enterprise systems.
• Perform impact assessments and coordinate system changes across Quality, Lab, Manufacturing, and IT.
• Support validation activities, including requirements, risk assessments, traceability, and documentation.
• Ensure data integrity, audit trails, electronic records, and e-signature compliance.
• Investigate issues, troubleshoot configuration, and implement corrective actions.
• Develop SOPs, work instructions, and governance documentation.

Skills

Windchill change management

Document control

Product lifecycle processes

LabVantage LIMS experience

GMP knowledge

FDA 21 CFR Part 11 knowledge

GAMP 5 knowledge

Change control processes

Analytical troubleshooting

Stakeholder management

Willingness to visit Juárez plants

Tools

SQL

SAP

ETQ

Empower

Maximo

Job description

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.

The role supports Windchill change management processes and LabVantage LIMS implementation, including system changes, validation activities, compliance requirements, troubleshooting, enterprise system integrations, and system governance documentation.

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.

Main 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.
• Willingness to visit the Juárez plants as needed.

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.