Enova Consulting
3 days ago
MES Engineer (m/f)
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Company information
- Company
- Enova Consulting
- Location
- Lausanne Germany
- Posted
- 3 days ago
Job description
Context
As part of digital transformation projects within an international group in the life sciences sector, we are looking for an MES Engineer – Qualification & Deployment to support the evolution and deployment of industrial IT solutions across several sites in Europe.
You will be involved in the qualification of an MES (Manufacturing Execution System) solution, intended to support and optimize production processes, while ensuring its compliance with the quality and regulatory requirements of the sector.
This position combines software qualification activities, computerized system validation, and deployment support. You will collaborate with local and international teams to ensure a coherent implementation of the solution, in compliance with current standards and best practices.
Your Role and Missions
Your Role
As an MES Engineer – Qualification & Deployment, you will play a key role in system qualification and supporting its deployment on various European sites.
You will ensure the reliability, compliance, and proper integration of the solution into the relevant industrial environments.
At the interface between IT teams, production teams, quality stakeholders, and project teams, you will contribute to securing the different stages of the solution's life cycle, from the preparation of qualification activities to its operational commissioning.
🎯 Missions
🔹 MES System Qualification & Validation
* Participate in the definition and execution of the MES software qualification and validation strategy.
* Write, review, and execute test protocols and validation documentation.
* Prepare and conduct functional tests, integration tests, and non-regression tests.
* Identify, document, and track anomalies until their resolution.
* Ensure traceability of requirements, tests, and qualification results.
* Ensure compliance with quality procedures and regulatory requirements applicable to computerized systems.
🔹 International Deployment
* Participate in the deployment of the MES solution on several sites in Europe.
* Support local teams in the preparation, execution, and validation of deployment activities.
* Contribute to the adaptation of the solution to the operational specificities of the different sites, while respecting defined standards.
* Coordinate activities with international project teams and local stakeholders.
* Participate in the preparation of go-lives and the monitoring of the initial operational phases.
🔹 Documentation & Compliance
* Write and maintain technical and quality documentation related to qualification activities.
* Ensure the compliance of deliverables with internal procedures and sector-specific requirements.
* Participate in the preparation of quality reviews and audits, when necessary.
* Contribute to the continuous improvement of qualification and deployment processes.
🔹 Collaboration & Support
* Collaborate with IT, quality, production, and business teams to ensure a common understanding of needs.
* Facilitate communication between central teams and local teams at different sites.
* Provide methodological and functional support during testing and deployment phases.
* Participate in knowledge transfer and support for the users concerned.
Your Profile:
* Higher education in IT, industrial systems, automation, engineering, or an equivalent field.
* Experience in software qualification, computerized system validation, or MES solution validation.
* Good understanding of regulated industrial environments, ideally in the pharmaceutical, biotechnology, or life sciences sectors.
* Knowledge of validation methodologies and good documentation practices.
* Experience in writing and executing test protocols, as well as in anomaly management.
* Understanding of compliance requirements applicable to computerized systems in regulated environments, particularly GxP principles.
* Experience in deploying solutions across multiple sites is a significant asset.
* Ability to collaborate with technical, quality, and business stakeholders in an international environment.
* Excellent writing skills, rigor, and organizational skills.
* Autonomy, analytical skills, and ability to manage multiple activities in parallel.
* Proficiency in French and English, both spoken and written, essential for working in an international context.
* Availability for occasional travel to different European sites, depending on project needs.
🏆 Position Conditions
* 📍 Location: French-speaking Switzerland
* 🕒 Workload: 100%
* 💼 Contract Type: Consulting Assignment
* 📅 Start Date: Flexible / January 2027
* 🌍 Environment: International and multi-site
* ✈️ Travel: Possible in Europe depending on project needs
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Required skills
- english
- production
- it
- consulting
- validation
- quality
- project management
- french
- gxp
- regulatory compliance
- pharmaceutical
- qualification
- deployment
- biotechnology
- computerized systems
- life sciences
- mes
- integration tests
- international
- traceability
- manufacturing execution system
- multi-site
- anomalies
- non-regression tests
- test protocols
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