The Opportunity:
Avantor is looking for a Digital Tulip MES Engineer to join our Digitization Operations team!
What we’re looking for
- Education: Bachelor’s degree and/or equivalent experience, education and training
- Experience: 2–5 years of experience with MES software applications, including implementation and deployment
- Demonstrated proficiency and hands-on experience with Tulip strongly preferred
How you will thrive and create an impact
The MES Engineer is a COE technical role 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 MES 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
- 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.
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.