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.
What you’ll do
Generate product optimization ideation in collaboration with an R&D multidisciplinary group
Develop applications in high level language (XML) translating a manufacturing biological process into machine instructions
Develop good practice guidelines for performing system/application verification and validation activities and organize standardization and harmonization within the application team
Set-up Design of Experiments (DOE) and perform verification and validation activities, and/or review plan and results within the application team, with focus on quality, compliance and execution rigor.
Establish acceptance criteria, assess through modelling or qualitative/quantitative testing, evaluate the performance.
Learn, master and ensure harmonization in the team the usage of tools for development, V&V and project management.
Manage change control activities on our commercialized product lines
Manage the product documentation throughout the Product Life Cycle Management
Work in a matrix organization with close collaboration with the product management, project management, engineering and biological teams among others
Work with the regulatory, product management and technical documentation teams to ensure application and/or product compliance with medical and GMP regulations
Mitigate project risks, deliver on-time, communicate effectively and resolve conflicts and encourage constructive dialogue in project teams
Ensure compliance with ISO13485, ISO9001 or GMP standards and other QMS requirements and take the lead on process optimization to avoid inefficiencies.
Who you are
University degree or equivalent in related scientific or engineering fields (physics, engineering, or life science)
10+ year work experience in R&D in the Life Sciences sector
Must have a successful experience working in product development and product care in a multidisciplinary environment, involving know-how in cell biology.
Demonstrated experience in launching products following a development cycle involving proof of concept, design, verification & validation plan under a quality management system
Proven experience in developing high level software using development methodologies and source code management (e.g. Agile, Waterfall, GitHub)
Expertise in statistical methods for creation of sampling plans required to meet acceptance of technical specifications
Have a deep understanding of interface between instrumentation and cell manipulations
Experience in supporting harmonization and standardization of growing R&D team and practices
Ability to navigate in ambiguous situation and resolve issues on-time
Demonstrated ability to clearly communicate (oral, written) across global, cross-cultural, cross-functional teams and stakeholders
Knowledge and practical experience of relevant regulations (ISO 9001, ISO13485, cGMP), specifically for the US and European market
Fluent in English, a second language is a plus
Customer-oriented mindset, autonomous at work, creative and initiatives welcomed
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 global life sciences leader with over 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. 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.