Lead Modeler

Position Overview

The Lead Modeler is responsible for driving MES modeling activities within Rockwell PharmaSuite, providing technical leadership, ensuring consistent quality, and coordinating a distributed modeling team. This role combines strategic design decisions, hands‑on modeling oversight, cross‑system integration alignment, and active participation in SCRUM processes.

Key Responsibilities:

1. Modeling Leadership

• Lead and coordinate the MES modeling team (onshore & offshore), ensuring timely, high‑quality delivery.
• Provide technical leadership and enforce best practices in Rockwell PharmaSuite modeling, templates, and workflows.
• Drive design decisions for batch, recipe, and process modeling in accordance with project and platform standards.
• Conduct peer reviews, testing cycles, and quality gate reviews to maintain consistency, compliance, and adherence to guidelines.
• Assess team capabilities, identify improvement areas, and drive continuous professional development.

2. Modeling Execution

• Translate (G)MBR and recipe requirements into executable modeling strategies and workshop deliverables.
• Design, maintain, and optimize MBR /(G)MBR templates and modeling concepts within Rockwell PharmaSuite.
• Proactively identify and resolve blockers; implement mitigation strategies to prevent future issues.
• Manage sprint planning, workload distribution, and task prioritization in collaboration with customers and stakeholders.

3. Technical Oversight & Integration

• Ensure MES modeling aligns with system architecture and integrates seamlessly with ERP, LIMS, SCADA, and other connected systems.
• Maintain detailed design documentation, configuration guides, SOPs, and related materials in line with GMP and GAMP5 requirements.
• Support validation activities, documentation updates, and change control processes.
• Participate in Wet Testing, Hypercare support, and defect resolution activities.

4. SCRUM & Communication

• Collaborate closely with the SCRUM Master on sprint planning, backlog refinement, and delivery tracking.
• Review, validate, and close JIRA tasks completed by the modeling team.
• Act as the Single Point of Contact (SPOC) for all PharmaSuite modeling‑related communication: scope clarification, priorities, timelines, risks, and dependencies.

Requirements:

• Deep knowledge of Rockwell PharmaSuite MES modeling (recipes, batches, processes, templates).
• Strong understanding of regulated pharma environments, including GMP and GAMP5 guidelines.
• Experience integrating MES with ERP, LIMS, SCADA, and similar enterprise systems.
• Strong leadership skills with experience managing distributed teams.
• Excellent communication, problem‑solving, and decision‑making abilities.
• English: B2–C2 (Upper‑Intermediate or higher).
• Additional languages (nice to have): German, French, Italian.