Tulip MES Engineer

Digital Tulip MES Engineer
The Digital Tulip MES Engineer is a COE technical lead responsible for designing, deploying, and sustaining Tulip applications within a GMP-regulated pharmaceutical manufacturing environment. This role blends process engineering, low-code development, and compliance-focused digital transformation to improve batch execution, documentation accuracy, deviation reduction, and overall plant performance. The engineer partners with QA, Operations, IT/OT, Validation, and corporate digital teams to ensure Tulip solutions meet regulatory requirements while driving operational excellence.

Key Responsibilities
1. Tulip Application Development & Deployment
· Build and deploy GMP-compliant Tulip apps for:
o Electronic batch records (EBR) and batch execution steps
o In-process quality checks and sampling workflows
o Equipment setup, cleaning, and line clearance verification
o Material dispensing, weighing, and traceability
o Deviation capture, CAPA workflows, and audit trails
· Configure connectors to integrate Tulip with UNS, ERP, LIMS, historians, SCADA/PLC systems, and other validated platforms.
· Develop dashboards to provide real-time visibility into batch progress, quality metrics, and equipment performance.
2. Compliance, Validation & Documentation
· Ensure all Tulip applications comply with GMP, GAMP 5, 21 CFR Part 11, Annex 11, and data integrity (ALCOA+) principles.
· Create and maintain validation documentation (URS, FRS, IQ/OQ/PQ, risk assessments, change controls).
· Partner with QA and Validation teams to ensure audit readiness and proper lifecycle management of digital systems.
· Maintain secure, traceable, and compliant electronic records and audit trails.
3. Support, Sustainment & Continuous Improvement
· Provide day-to-day support for Tulip apps, connectors, and edge devices in a validated environment.
· Troubleshoot issues related to data integrity, device connectivity, and workflow logic.
· Monitor system performance, user adoption, and data quality; drive continuous improvement initiatives.
· Maintain version control, documentation, and change management in alignment with GMP expectations.
4. Workforce Training & Change Management
· Train operators, supervisors, QA personnel, and engineers on new Tulip workflows.
· Develop SOPs, training materials, and job aids that meet regulatory documentation standards.
· Promote a culture of digital adoption, right-first-time execution, and data-driven decision-making.
5. Cross-Functional Collaboration
· Partner with QA, Validation, and IT/OT to ensure secure, compliant, and reliable