Qualification Services Systems Engineer

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher's 15+ operating companies, our work saves lives - and we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

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. Take your next step to an altogether life-changing career.

The Qualification Services Systems Engineer is responsible for creating content to help assist our customers to document the qualification of Cytiva equipment on the customer site.

This position reports to the Qualification Content Engineering Manager and is part of the Qualification Service team located at the Marlborough facility in MA and will be an on-site role.

What you will do:

• Support NPI team projects within Qualification Services (QS) business with creation of test protocols for Cytiva commissioning and qualification documentation for new systems, automation and solution offerings.
• Support in the life cycle management of test protocols, analysing software and hardware changes to determine impact on current offering or requirement for additional testing.
• Adapt and create test protocols to align to custom requirements and manage delivery on time to project/customer deadlines.
• Ensure high quality and continuous improvement to content by simulating testing on equipment when required, travelling to location of equipment as required.
• Support the broader service team providing subject matter expertise and input to update service information and training content for Field Service Engineering team.

Who you are:

• Degree in Engineering or significant technical/quality service background.
• Familiarity with 21 CFR Part 11, GAMP 5, Annex 11, GxP, and other regulatory standards. Minimum of 4 years of experience in associated field.
• Ability to understand and interpret technical product documentation.
• Experience working within a QMS environment to ensure quality standards in commissioning and qualification documentation.
• Able to work with a remote global team to meet project goals within agreed timelines.

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 and/or software control platforms, including experience in creating and/or executing validation and verification documentation.
• Demonstrated skills in documenting technical information or protocol development.

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

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 our website.

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.

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 to request accommodation.