Danaher Corporation Hiring For R&D Biotechnology Systems Engineer at Marlborough, MA Full Time

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. Your health and wellbeing are important to us and together we will not compromise on safety in the workplace or the environment.

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.

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, support hardware and software architecture definition, lead system verification and validation planning and verify completion, and manage 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 related scientific or engineering fields (physics, engineering, or life science). A Ph.D. with a focus on life science instrumentation or similar is a plus.

• 10+ years of successful experience working in product and 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, software and automation software (PLC-SCADA, DCS) 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

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 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 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.

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 ***************@danaher.com to request accommodation.

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