R&D SENIOR APPLICATION ENGINEER (m/f/d)

  • Cytiva
  • Eysins, VD, Switzerland
  • 11/06/2021
Full time Data Science Data Analytics Big Data Data Management Statistics

Job Description

Be part of something altogether life-changing

Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

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

When you join us, you’ll also be joining Danaher’s global organization, where 68,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out.