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 (., 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.
Equipment Qualification Engineer • Neuchâtel, NE, CH
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