Be part of something altogether life-changing!
Working at Cytiva 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.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
As a “Senior/Product Stewardship Engineer”, you will be working on the global compliance/regulatory projects which involve the assessment of substances used in the Cytiva products. Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations. Investigates and resolves compliance problems, questions, and complaints. Overall, support the product team to meet compliance and regulatory requirements as part of the product development life cycle.
This position is part of the Quality and Regulatory Affairs located in Bangalore and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
In this role, you will have the opportunity to:
Responsibility includes hands-on working on the Compliance/Regulatory projects for Cytiva.
Assessment of the substances used in Chemical products, Engineering Hardware (both Electrical and Mechanical), and change management of substances as per restrictions, regulatory needs, and sustainability for the same.
Keeping data on regulations up to date to drive competitive advantage and increase responsiveness to customer tenders.
Cross-functional interactions with Product Care teams, Global Marketing, Sourcing, Engineering, Database administrators, Service, and Manufacturing organizations.
Communicate with suppliers on regulations and collect material data as required.
Retrieve relevant information from engineering, standards bodies, industry standards, and other technical resources to develop an overall Cytiva life sciences environmental strategy and drive change.
The essential requirements of the job include:
Bachelor of Engineering degree in Material Science/Chemical Engineering or Equivalent.
A minimum of 5 to 10+ years industrial experience in sustainability, eco-design and/or product related environmental regulations applicable for engineering products
Good knowledge of applicable environmental regulatory requirements and industry standards, including WEEE, RoHS, REACH, Animal origin, Country of origin, Low voltage directive, Machinery directive, Battery directive, other eco-design and energy efficiency requirements
Proven expertise in developing hardware substance (metals, non-metals, plastics, semiconductor devices) compliance matrix with respect to above mentioned regulatory requirements
Expertise in Material Risk Assessment.
Ability to develop standards, processes, SOPs and execute projects globally.
Familiar with product life cycle thinking and use of product life cycle assessment software or tools to evaluate the eco-profile of products
Good in development of processes, SOPs and communication skills
It would be a plus if you also possess previous experience in:
Good knowledge on CE/UL/ETL/IEC standards and how they apply to designs
Good knowledge on regulations related to Life sciences products will be a huge advantage
Experience in design documentation to comply with ISO and European standards
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
At Danaher, 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.