Digital Tulip/MES Engineer

Job Description:

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.

Responsibilities

• Tulip Application Development & Deployment

• Build and deploy GMP ‑ compliant Tulip apps for:

• Electronic batch records (EBR) and batch execution steps

• In ‑ process quality checks and sampling workflows

• Equipment setup, cleaning, and line clearance verification

• Material dispensing, weighing, and traceability

• 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.

• 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.

• 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.

• 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.

• Cross ‑ Functional Collaboration

• Partner with QA, Validation, and IT/OT to ensure secure, compliant, and reliable infrastructure for Tulip deployments.

• Collaborate with process engineering and operations to embed Tulip into new equipment, processes, and capital projects.

• Work with corporate digital teams to align with enterprise architecture, cybersecurity, and digital strategy.