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Danaher Corporation R&D Quality Engineer (m/f/d) in Eysins, Switzerland

Help us improve access to life-changing therapies that can transform human health

We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.

Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.

We are looking for a R&D Quality Engineer (m/f/d) to work with our expert Cell and Gene Therapy global R&D team consisting of +100 associates across the world. Do you have a passion for improving product quality and in biological cell processing automation and developing the culture and rigor within R&D teams Then we would love to hear from you.

What you’ll do

  • Provide quality engineering support in cross-functional change control activities to ensure that technical and document impact assessments are performed in a compliant manner and DMR/DMF and recording are kept updated.

  • Support hardware, software, application and disposable kit’s teams during project planning and development phases to define qualification strategy and acceptance criteria

  • Review verification and validation documents with functional teams, ensuring the documentation meets compliance requirements and quality standards

  • Perform and document technical root cause investigation in close R&D collaboration with hardware, software, application and disposable kit system matter experts.

  • Track, review and report metric information related to Complaints/NC/CAPAs and deviation

  • Master processes and tools and take the lead on process/tools/document template optimization to improve the overall design control or change control process efficiency

  • Work closely with cross-functional teams, like quality affairs, regulatory affairs, supply chain, and other functions to ensure alignment and compliance during product quality resolution

  • Support company goals and objectives, policies and procedures in compliance with quality manual and quality system processes

  • Participate in regulatory agency inspections and audits of the facilities and ensure corrective actions are performed as necessary

  • Create a culture of quality awareness, teamwork and cooperation within all groups of the R&D department

Who you are

  • University degree or equivalent in engineering, quality or regulatory fields

  • Proven track record to create, review, and execute qualification protocols (IQ/OQ/PQ) and associated validation lifecycle documentation, including identification and resolution of non-conformances /deviations

  • 5+ years’ experience in MD or GMP regulated environment with strong understanding of cGxP standards and risk based validation

  • Knowledge and practical experience of relevant regulations (ISO 9001, ISO13485, cGMP), specifically for the US and European market

  • Well-founded understanding of equipment system engineering disciplines, with preferably a good understanding of human cell biology

  • Technical knowledge of qualitative and quantitative data analysis, and statistical tools

  • Strong critical thinking, analytical and problem-solving skills

  • Self-starter able to work both independently and as part of a multi-disciplinary team

  • Customer-oriented mindset, good organizational skills, creative, and comfortable with change

Who we are

Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.

Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!

Cytiva is a 3.5 billion USD global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to help us improve access to life-changing therapies that transform human health. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.

Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.

Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.

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