Senior PLM & LIMS Systems Engineer

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.