Danaher Corporation Associate Senior Systems Engineer in Uppsala, Sweden
Associate S Senior Systems Engineer – R&D Biotechnology
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.
The R&D Biotechnology Systems Engineer will be responsible for defining system requirements, scouting and assessing existing technologies, highlighting technological gaps, working with subject matter experts to propose a catalogue of solutions, supporting hardware and software architecture definition, leading system verification and validation planning and verifying completion, and managing project documentation working along with internal and external stakeholders.
What you’ll do
Participate in biomanufacturing process analysis and user requirement definition along with internal and external stakeholders.
Lead the definition of system and sub-system requirements in accordance with user requirements
Drive technology scouting and assessment of available biomanufacturing instruments and related technologies for cell therapies
Drive strategy, surveillance, and gap analysis of technologies available for cell therapies
Formulate and drive verification and validation activities, including test plan definition and execution with focus on quality, compliance, and execution rigor
Establish requirements acceptance criteria, asses through modelling or qualitative / quantitative testing with statistical rigor, and evaluate the performance
Lead the technical project roadmap including documentation strategy (i.e. DHF) and traceability.
Work in close collaboration with the product manager, project manager, engineering team and external partner, and take the lead to translate between the parties to facilitate the definition and realization of a successful system
Work in close interaction with other relevant stakeholders such as production, supply chain, quality, marketing, external suppliers and end-users
Mitigate project risks, deliver on-time, communicate effectively and resolve conflicts and encourage constructive dialogue in project teams
Ensure compliance with ISO 9001, 21 CFR Part 11 or other relevant standards such as ISO 13485
Who you are
University degree or equivalent in scientific or engineering fields (physics, engineering, or life science). Bachelor’s or Master’s Degree with minimum 8 years of relevant experience. PhD with minimum 4 years of relevant experience.
Experience working in product / process development and validation in a multidisciplinary environment, ideally involving hardware, automation software, and single-use technologies in life science or medical fields
Proficient in systems engineering and well-founded understanding of mechanical, electrical, and software engineering disciplines , complemented by solid understanding of biomanufacturing processes and human cell biology
Successful experience with product lifecycle including definition of complex system and sub-system requirements, designing hardware/software architecture, verification and validation planning and execution under a quality management system
Experience in manipulating and using a broad range of biotechnologies used in processing chemical compounds and/or live organisms
Passionate about technology scouting, reading and absorbing scientific publications, mapping technical value propositions and monitoring related intellectual property
Demonstrated ability to clearly communicate (oral, written) across global, cross-cultural, cross-functional teams and stakeholders
Practical experience of technical standards such as IEC 61326, IEC 61010, ISA-88/95, etc.
Knowledge and practical experience of relevant regulations (ISO 9001, 21 CFR Part 11, ISO 13485), specifically for the US and European market
Customer-oriented mindset, autonomous at work, good organizational skills, creative, and comfortable with change
Fluent in English, a second language is a plus
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 (https://jobs.danaher.com/global/en/cytiva) , Instagram channel (https://www.instagram.com/cytiva/) and LinkedIn page (https://www.linkedin.com/company/cytiva/) !
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.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Given the essential job duties of this position, the employee is required to be fully vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation and applicable law.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.