Capgemini Engineering Ukraine

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.

Position Overview

The Technical MES Project Manager is responsible for coordinating assessments, managing stakeholders, and leading technical evaluation activities within MES environments such as PAS‑X, Rockwell FactoryTalk, and FactoryTalk PharmaSuite. This role ensures alignment across teams, comprehensive system analysis, and clear migration or enhancement recommendations.

Key Responsibilities

1. Stakeholder Management

• Manage, coordinate, and align all internal and external stakeholders throughout the assessment process.
• Ensure effective communication, timely information exchange, and proper documentation of stakeholder requirements.

2. Assessment & Analysis

• Conduct a comprehensive assessment of the current MES environment (PAS‑X or Rockwell FactoryTalk / FactoryTalk PharmaSuite), covering technical, functional, architectural, and operational aspects.
• Identify and evaluate system gaps, dependencies, risks, required upgrades, and integration impacts associated with potential system migration or transformation.

3. Technical Evaluation

• Collaborate with relevant business functions and technical teams to analyze feasibility, system prerequisites, and potential implementation scenarios.

Requirements:

• Experience with MES platforms (PAS‑X, Rockwell FactoryTalk, PharmaSuite) — technical understanding preferred.
• Strong analytical and assessment skills in regulated or complex system landscapes.
• Ability to evaluate architecture, integrations, system dependencies, and migration risks.
• Strong stakeholder management and communication abilities.
• English: B2–C2 (Upper‑Intermediate or higher).
• Additional languages (nice to have): German, French, Italian.

Job Description

Responsible for creating, updating, and reviewing manufacturing models, recipes, and electronic batch records in Rockwell PharmaSuite in line with project specifications and quality standards.

Key Responsibilities:

· Create, update, and review models, recipes, and EBR elements in Rockwell PharmaSuite.

· Ensure modeling deliverables comply with GMP and GAMP5 guidelines.

· Collaborate with the Lead Modeler and onsite team to clarify requirements and align priorities.

· Participate in workshops and sprint planning; communicate blockers and support resolution.

· Maintain accurate modeling documentation and support peer reviews.

· Execute tasks within agreed timelines and report progress via JIRA or service trackers.

Requirements:

· Hands-on experience with Rockwell PharmaSuite (MES modeling/configuration).

· Knowledge of GMP and GAMP5 in regulated pharma environments.

· Experience with recipe, batch, or process modeling.

· Upper-Intermediate English (B2) or higher.

· Nice to have: German, French, or Italian; Agile/Scrum experience.