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.