Windchill & LIMS Systems Engineer — Validation & Compliance

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 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.