Technical Lead - Qualification Services Automation Engineer

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.

The Qualification Services Automation Engineer for Cytiva is responsible for ensuring that our products, processes, and systems meet specified quality standards and regulatory requirements.

This position is part of the Qualification Services team and is located at the Marlborough facility in MA, USA and will be based onsite. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

What you will do:

• Supporting project management and NPD team projects within Qualification Services (QS) business with creation and management of technical aspects of master document templates.

• Manage and lead the technical generation of content for multiple programs within the Qualification Services business.

• Creation of quality Commissioning and Qualification (C&Q) documentation from system technical/design documents and guidance from subject matter experts.

• Analyse software and hardware changes to determine impact on current offering or requirement for additional testing.

• Support the broader QS team in customer facing projects.

Who you are:

• 5+ years of experience

• Bachelor's degree in Electrical Engineering, Automation Engineering, Quality Assurance or a related field.

• Proven experience in designing, qualification engineering, quality assurance, or a similar role within a regulated industry.

• Training or certification in DeltaV, PlantPAx and/or AVEVA system administration

• Familiarity with 21 CFR Part 11, GAMP 5, Annex 11, GxP, and other regulatory standards. Minimum of 4 years of healthcare experience.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Willingness to travel globally, up to 25% of the time

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

• Demonstrated capability in performing execution of Commissioning and Qualification of large complex custom and/or Flex Factory Projects.

• Understanding and experience of field service actions for multiple Cytiva system platforms.

• Experience in creating and/or executing validation and verification documentation.

• Able to work with a global team to meet project goals within agreed timelines.

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.

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 [email protected] to request accommodation.