Senior

PLM & LIMS

Systems Engineer BEPC Inc - 3.9 El Paso, TX Job Details Contract $37 - $40 an hour 1 day ago Benefits Health insurance Dental insurance Vision insurance Life insurance Qualifications Bilingual Stakeholder engagement System administration GAMP Document control experience within pharmaceutical industry Pharmaceutical regulatory compliance SAP Configuration management

FDA 21 CFR

Part 11 System maintenance System testing Compliance documentation Systems engineering Stakeholder relationship building Product lifecycle management Stakeholder management

Full Job Description 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. Required 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. 70% Bilingual 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.

MXOPS Pay:

$37.00 - $40.00 per hour

Benefits:

Dental insurance Health insurance Life insurance Vision insurance

Work Location:

In person