QA Engineer - Process Validation - all genders

Work Your Magic with us!  

Ready to explore, break barriers, and discover more? We know you-ve got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people-s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

YOUR ROLE

An exciting new opportunity has arisen to join us as-Quality Assurance Qualification & Validation Engineer-for our Biotech drug substance plant in Corsier-sur-Vevey. 

As an integral member of the Quality Unit, you will:

• Primarily provide QA expertise in Process Validation, with potential involvement in Equipment Qualification (including sterilization), Cleaning Validation, Raw Material Qualification, and Computerized System Validation as needed.
• Elaborate the qualification/validation strategies and review/approve related protocols and reports.
• Participate in risk analyses, identify gaps, and propose remediation plans.
• Act as a Quality Subject Matter Expert on specific topics and support risk assessments and handle deviations on these topics.
• Review and/or approve qualification/validation documents, risk assessments, SOPs and take quality decisions according to company standards. 
• Oversee qualification/validation phases from Basic Design until 1st use of equipment/raw material.
• Ensure GMP compliance throughout all qualification/validation phases.

YOUR PROFILE

• Degree in Life Sciences, Engineering, or a related field (e.g., Biochemistry, Biotechnology, or Pharmaceutical Science).
• Proven experience (4-9 years) in quality assurance, with expertise in qualification and validation processes in a GMP-regulated environment.
• Solid knowledge in Process Validation. Knowledge in Equipment Qualification, Raw Material Qualification and Cleaning Validation is a plus.
• Strong understanding of GMP guidelines and regulatory compliance requirements.
• Analytical mindset with experience in risk assessment, deviation handling, and remediation planning.
• Excellent organizational skills with the ability to review and approve technical documents such as protocols, reports, SOPs, and risk assessments.
• Effective communication and teamwork skills
• French & English written & spoken.

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!