Overview
Expleo offers a unique range of integrated engineering, quality, and strategic consulting services for digital transformation. Against a backdrop of unprecedented technological acceleration, we are the trusted partner for innovative companies. We help them develop a competitive advantage and improve the daily lives of millions of people.
We are looking for a qualified and experienced Equipment Qualification Engineer or Scientist to contribute to a major revamping project within a pharmaceutical manufacturing area. The successful candidate will be a key member of the project team, responsible for the coordination and execution of qualification and commissioning activities for new production equipment and associated systems.
This position is part of the Manufacturing Sciences & Technology (MS&T) department and involves close collaboration with engineering, validation, quality assurance, end users, and external suppliers. The ideal profile brings at least 5 years of experience in GMP-regulated environments, supporting capital projects through their entire lifecycle.
Key Responsibilities
* Serve as a subject matter expert for qualification and commissioning activities.
* Lead all phases of qualification: Design Qualification (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), commissioning, qualification execution, and close-out.
* Ensure alignment with internal validation standards and regulatory expectations.
* Partner with cross-functional teams (MS&T, QA, Engineering, Operations, vendors) to ensure seamless execution of qualification deliverables.
* Prepare, review, and approve qualification documentation such as plans, protocols, and reports.
* Support Computerized System Validation (CSV) where applicable.
* Investigate deviations, manage change controls, and oversee corrective/preventive actions related to equipment qualification.
* Participate in audit preparation and act as SME during inspections.
Qualifications
* Degree in engineering, life sciences, or a related technical field (e.g., mechanical, chemical, or process engineering).
* At least 5 years of experience in equipment qualification and validation in a GMP-compliant pharmaceutical or biotech environment.
* Solid understanding of qualification processes and documentation standards.
* Proven experience managing complex technical deliverables and collaborating across teams.
* Strong communication skills, with the ability to document clearly and influence stakeholders.
* Fluency in English; French is an asset.
* Previous experience supporting regulatory audits is considered a plus.
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