R&D Quality Engineer (m/f/d)
Cytiva
Eysins, Switzerland
vor 3 Tg.

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.

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