Qualification & Engineer

As a Qualification & Validation Engineer, you will be responsible for defining, coordinating, executing, and documenting qualification and validation activities related to equipment, utilities, facilities, computerized systems, and manufacturing processes. You will ensure compliance with GMP, FDA, ISO, and internal quality requirements while supporting operational excellence and maintaining systems and processes in a validated and inspection-ready state throughout their lifecycle. You will :

This role requires strong technical expertise, attention to detail, and the ability to work cross-functionally in a regulated environment to ensure product quality, patient safety, and compliance. YOUR COMPETENCIES

WHAT WE OFFER

Interested ? We invite you to send your application, including your resume and any other relevant documents. We look forward to exploring your potential contributions to AliveDx. AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, religion/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.

• Develop, validate, and implement analytical methods supporting product development, manufacturing, and release.
• Define and execute qualification and validation strategies for equipment, systems, utilities, and manufacturing processes
• Coordinate and perform qualification and validation activities including IQ/OQ/PQ, process validation, and requalification activities
• Draft and maintain validation documentation including URS, risk assessments, protocols, reports, SOPs, and technical procedures
• Ensure validation activities and documentation comply with GMP, GDP, FDA, ISO, and internal quality standards
• Collaborate closely with Engineering, Manufacturing, QA, and QC teams to support implementation of new equipment and process improvements
• Support deviation investigations, root cause analysis, CAPA, and change control activities impacting validated systems
• Participate in audits, inspections, and continuous improvement initiatives to maintain operational and regulatory compliance
• Bachelor or Master degree in Engineering, Life Sciences, or related field
• Minimum 2–5 years of experience in qualification/validation within a regulated industry (medical devices, pharma, biotech)
• Strong knowledge of GMP, GDP, FDA, and ISO requirements and quality systems
• Experience in drafting and reviewing technical and GMP documentation
• Good understanding of qualification and validation lifecycle methodologies and risk-based approaches
• Experience with deviation investigations, CAPA, and Change Control processes
• Strong analytical, organizational, and problem-solving skills with the ability to manage multiple priorities
• Fluent in French and English (written and spoken)
• A highly dynamic and growing environment,
• An opportunity to live your passion for an intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do,
• A flexible working environment where applicable and a range of core and flexible benefits, ranging from lunch allowance support, additional annual leave, cycle to work scheme, technology and access to marketplace discounts.