MES Technical Lead

Le besoin

Client Context

The client is a major international pharmaceutical group operating in a highly regulated manufacturing environment.

Mission Context

The mission is part of a major industrial and digital transformation program within a highly regulated environment. The client is deploying a Manufacturing Execution System (MES), the Rockwell PharmaSuite MES (a leading solution in the pharmaceutical industry), across several manufacturing sites with the objective of strengthening production reliability, ensuring data integrity, and standardizing operational processes.

The MES rollout involves multiple stakeholders across IT, Manufacturing, Quality, Automation, and external partners (Rockwell Automation, system integrators, equipment suppliers). It spans the full deployment lifecycle, including design, configuration, integration, validation, and go-live activities.

The environment combines strong regulatory constraints (GxP, 21 CFR Part 11, Annex 11, GAMP 5), complex system integrations (SAP, LIMS, historians, PLCs/equipment), and parallel deployment and design streams across sites.

In this context, the consultant, as the MES Technical Lead, will play a central role in ensuring that Rockwell PharmaSuite is technically robust, compliant, scalable, and aligned with both business processes and IT standards, while supporting cross-site harmonization and successful deployment from pilot to global scale.

Mission Objectives

The main objective of the mission is to ensure the successful technical design, integration, validation, and deployment of Rockwell PharmaSuite MES across the client’s manufacturing sites. As the MES Technical Lead, the consultant will be responsible for guaranteeing that the solution is robust, compliant, scalable, and seamlessly integrated into the client’s IT/OT landscape, while enabling reliable and compliant pharmaceutical production operations.

During the assignment, the consultant is expected to achieve the following objectives:

1. Technical Design & Configuration Excellence

• Deliver complete and compliant MBR/EBR designs aligned with site processes.

• Ensure 100 traceability of technical decisions and configuration artifacts.

• Guarantee solution scalability and performance across all targeted sites.

• Validate that PharmaSuite configuration adheres to group-wide MES standards.

2. Integration Performance & Reliability

• Achieve stable and validated interfaces with SAP, LIMS, historians, PLCs, and equipment.

• Ensure data integrity KPIs (no loss, mismatch, or duplication across MES–ERP layers).

• Reduce integration-related production incidents by >90 through robust design.

• Ensure proper integration with shop-floor equipment and automation systems (PLCs, OPC, SCADA).

• Deliver integration documentation covering all interface specifications and workflows.

3. Regulatory Compliance & Validation

• Ensure full alignment with 21 CFR Part 11, Annex 11, and GAMP 5.

• Deliver validated technical documentation: URS, FDS, IQ, OQ, PQ.

• Achieve 0 critical or major findings in internal/external audits related to MES.

• Maintain controlled change management and version control across all deliverables.

4. Deployment Success & Site Readiness

• Support pilot deployment and achieve successful go-live with no major blocking issue.

• Ensure site teams reach operational autonomy on PharmaSuite configuration and usage.

• Lead hypercare and stabilize the solution within the defined performance window.

• Reduce deployment cycle time across sites through reusable templates and standards.

5. Continuous Improvement & Sustainment

• Identify opportunities to improve system performance or usability.

• Contribute to product governance and change control with structured technical insights.

• Ensure PharmaSuite enhancements are deployed with validated technical impact analysis.

• Keep system documentation, configurations, and standards continuously up to date.

Scope and Consultant Responsibilities

In line with the Mission Objectives, the consultant will be responsible for delivering the technical, integration, validation, and deployment activities required to ensure the successful implementation of the PharmaSuite MES solution. The scope of responsibilities includes:

1. Technical Leadership

• Lead the technical design and configuration of Rockwell PharmaSuite (MBR design, workflows, equipment integration).

• Manage and maintain user roles, access rights, and authorization rules within the MES environment.

• Ensure system scalability, reliability and security. Ensure system overall performance.

· Provide technical oversight to internal teams and external partners.

· Review, validate, and challenge the technical documentation (FDS, interface specs, testing documentation).

· Act as the technical counterpart to Rockwell Automation and system integrators.

2. System Integration

• Define, structure, and implement interfaces between the MES and all types of external systems: SAP, LIMS, historians, PLCs/equipment, and other enterprise applications.

• Ensure data consistency and alignment across the IT/OT layers.

• Support troubleshooting activities and root-cause analysis regarding integration failures.

3. Validation & Compliance

• Ensure consistent management of the MBR lifecycle, including versioning, testing, and deployment.

• Work closely with Quality and CSV teams to ensure compliance with GxP requirements.

• Contribute to, review and approve validation documentation (URS, FDS, IQ/OQ/PQ).

• Participate in audit readiness and support regulatory inspections as needed.

4. Deployment & Project Support

• Support the rollout of Rockwell PharmaSuite across manufacturing sites (from pilot to scale-up).

• Participate in go-live, hypercare (post-implementation support), and stabilization phases.

• Provide training and technical coaching to site teams.

• Identify risks, dependencies, and technical constraints, and propose mitigation strategies.

5. Continuous Improvement

• Suggest technical enhancements to improve system performance and user experience.

• Contribute to product governance and change control processes.

• Stay updated on PharmaSuite evolutions and digital manufacturing best practices.

Required Skills and Experience

Technical & Functional Skills

• Engineering degree in Automation, Computer Science, Industrial IT, or a related discipline from an internationally recognized engineering school or university (Note: 10+ years in MES, automation, or digital manufacturing may substitute for top school academic requirements)

• 5+ years of experience in MES implementation, ideally with Rockwell PharmaSuite.

• Strong experience in OPC/PLC communication, SAP integration, and equipment connectivity.

• Solid understanding of pharmaceutical manufacturing processes (dispensing, granulation, compression, packaging…).

• Solid knowledge of CSV / GxP and data integrity expectations.

• Ability to work in a regulated industrial environment and interact with IT/OT systems.

Nice to Haves

• Experience in multi-site MES rollout projects.

• Familiarity with Rockwell PharmaSuite specifics (PharmaSuite phases, core templates, etc.).

• Knowledge of Pharma 4.0 principles and digital manufacturing trends.

• Understanding of data integrity best practices and audit readiness.

Soft Skills

• Strong leadership and sense of ownership.

• Excellent communication and cross-functional coordination abilities.

• Structured and analytical mindset.

• Problem-solving orientation and autonomy.

• Strong team spirit and ability to collaborate with diverse stakeholders.

Languages

• Fluent English mandatory (C1 level minimum – C2 level is best)

• French is a plus.

Terms & Conditions

• Term: 6-month contract (renewable up to 5 times)

• Start date: ASAP

• Geographical Location: France (Paris or Orléans offices)

• Remote work: possible up to 2 days/week

• Travel: Occasional travel to manufacturing sites will be necessary

• Context: Regulated pharmaceutical environment, multi-site deployment

• Average Daily Rate: aligned with senior-level responsibilities and the expertise required for this role. Priority will be placed on securing the right profile.