Supplier Quality Engineer - Supplier Document Control

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

This Supplier Quality Engineer is part of the Supplier Quality global team and will be fully Remote. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

Do you have a passion for Supplier Quality? Then we would love to hear from you.

In this role, you will have the opportunity to:

• The Supplier Quality Specialist will collaborate with Material Science Engineering, Chemical Program Leader, Regulatory, Product Engineering, Quality Assurance and Sourcing teams on activities required to effectively manage supplier quality requirements per specification for direct chemical raw materials used in Bioprocess manufacturing (Cell Culture Media) including:

  • Supplier and sourcing change control workflow management and risk assessment

  • Supplier qualification documentation and workflow management

• Primary areas of focus will be documenting chemical supplier compliance across 4 sites globally by way of:

  • Monitoring all change controls submitted by suppliers.

  • Initiate impact assessments with appropriate stakeholders

  • Excel/Smartsheet file management

  • Risk classification of change

  • Assigning appropriate and detailed change actions to world-wide owners

  • Ensuring documented evidence of compliance is in place

  • Follow-up with key suppliers on requests for clarification of change.

• Liaison with stakeholders on metrics and supplier problem resolution to maintain progress and address high risk items discovered.

• Report to assigned US based Manager to assure supplier compliance to Cytiva QMS and regulatory requirements

The essential requirements of the job include:

• Demonstrated knowledge of Quality Management System tools.

• Ability to program and maintain Excel/Smartsheet applications.

• Demonstrated technical aptitude: strong background in interpretation of specifications, and manufacturing process planning / evaluation.

• Exposure to the use of digital solutions in Supplier Quality. (i.e. Veeva, Magic, Oracle ++)

• Degree in an engineering, technical discipline, or equivalent non-technical degree with experience in manufacturing, engineering, or quality assurance.

It would be a plus if you also possess previous experience in:

• Knowledge in manufacturing of Chemical/food grade commodities a plus.

At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. 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.