EC
Ingénieur MES (h/f)
Enova Consulting
Contract type
Freelance
Work mode
Remote · Switzerland
Experience
3 years
Job description
An MES Engineer for Qualification & Deployment will qualify and validate a Manufacturing Execution System and support its rollout across several European sites for an international life sciences group.
At a glance
- Employment
- Contract · Independent contractor
- Work mode
- Remote · Switzerland
- Languages
- French – fluent, English – fluent
What you'll do
- Define and execute the qualification and validation strategy for the MES software.
- Write, review and execute test protocols and validation documentation.
- Prepare and perform functional, integration and regression tests.
- Identify, document and track anomalies through to resolution.
- Ensure traceability of requirements, tests and qualification results.
- Ensure compliance with quality procedures and regulatory requirements for computerized systems.
- Support the deployment of the MES solution across several sites in Europe.
- Support local teams in preparing, executing and validating deployment activities.
- Adapt the solution to the operational specifics of each site while respecting defined standards.
- Coordinate activities with international project teams and local stakeholders.
- Prepare go-lives and monitor the first operational phases.
- Write and maintain technical and quality documentation related to qualification activities.
- Ensure deliverables comply with internal procedures and applicable sector requirements.
- Prepare quality reviews and audits when necessary.
- Contribute to continuous improvement of qualification and deployment processes.
- Collaborate with IT, quality, production and business teams to ensure a shared understanding of needs.
- Facilitate communication between central teams and local site teams.
- Provide methodological and functional support during testing and deployment phases.
- Support knowledge transfer and user onboarding.
What we're looking for
- 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 pharmaceutical, biotech or life sciences.
- Knowledge of validation methodologies and documentation best practices.
- Experience writing and executing test protocols and managing anomalies.
- Understanding of compliance requirements for computerized systems in regulated environments, notably GxP principles.
- Ability to collaborate with technical, quality and business stakeholders in an international environment.
- Excellent writing skills, rigor and organizational sense.
- Autonomy, analytical mindset and ability to manage several activities in parallel.
- Fluency in French and English, spoken and written, essential in an international context.
- Availability for occasional travel to the various European sites as project needs require.
Nice to have
- Experience deploying solutions across multiple sites is an important asset.