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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.

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.

The salary range for this role is $78,000- $88,000 . This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.

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. Check out our benefits at Danaher Benefits Info .

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 .

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 to request accommodation.

Average salary estimate

$83000 / YEARLY (est.)
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$78000K
$88000K

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What You Should Know About Qualification Services Systems Engineer, Cytiva

At Cytiva, our mission is to bring more to life, and as a Qualification Services Systems Engineer, you will play a pivotal role in making that happen. Located in Marlborough, MA, you’ll find yourself immersed in a culture that thrives on innovation, where your unique perspective truly matters. This on-site position is all about creating content that assists customers in documenting the qualification of Cytiva equipment at their sites. You’ll have the opportunity to work on new projects, helping the NPI team craft test protocols for commissioning and qualification documentation of our latest systems. It's a collaborative environment where you'll engage with a global team to ensure quality standards are met and projects run smoothly. You'll be tasked with adapting protocols to cater to custom requirements and delivering them right on time. And yes, expect to travel a bit, up to 25% of the time, which adds an exciting dimension to your role! You’ll ensure high quality and continuous improvement by simulating equipment testing when necessary. Your expertise will also resonate through service information updates and training content for our Field Service Engineering team. Join us at Cytiva, where together, we will accelerate the real-life impact of tomorrow's science and technology!

Frequently Asked Questions (FAQs) for Qualification Services Systems Engineer Role at Cytiva
What are the main responsibilities of a Qualification Services Systems Engineer at Cytiva?

As a Qualification Services Systems Engineer at Cytiva, your main responsibilities include creating test protocols for new systems, managing the lifecycle of testing protocols, and ensuring quality documentation in alignment with regulatory standards such as 21 CFR Part 11 and GxP. You'll collaborate with the NPI team, adapt testing protocols for custom requirements, and support the service team with expertise in service information and training.

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What qualifications are needed for the Qualification Services Systems Engineer position at Cytiva?

To qualify for the Qualification Services Systems Engineer role at Cytiva, you’re expected to have a degree in Engineering or substantial technical service experience, alongside at least 4 years in a relevant field. Familiarity with regulatory standards like GAMP 5 and experience in Quality Management Systems (QMS) are vital, along with the ability to interpret technical documentation.

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Is travel required for the Qualification Services Systems Engineer role at Cytiva?

Yes, the Qualification Services Systems Engineer at Cytiva requires a willingness to travel globally, up to 25% of the time. This travel is essential for simulating tests and ensuring effective equipment qualification on-site for various customer projects.

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What type of projects will a Qualification Services Systems Engineer at Cytiva work on?

A Qualification Services Systems Engineer at Cytiva will support NPI team projects by creating test protocols for commissioning and qualification of Cytiva's innovative systems and automation solutions. You’ll actively engage in customizing test protocols and managing their timely delivery according to project deadlines.

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What is the salary range for the Qualification Services Systems Engineer position at Cytiva?

The salary range for the Qualification Services Systems Engineer at Cytiva is between $78,000 and $88,000. This range reflects the company's commitment to providing competitive compensation and may be adjusted in the future.

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Common Interview Questions for Qualification Services Systems Engineer
Can you explain the importance of compliance with regulatory standards in your role as a Qualification Services Systems Engineer?

In your position as a Qualification Services Systems Engineer, compliance with regulatory standards such as 21 CFR Part 11 and GxP is crucial. It ensures that the equipment and processes meet quality and safety standards, which is essential for the life sciences and diagnostics fields. Reflect on your experience ensuring adherence to these regulations.

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Describe a past project where you managed the creation of test protocols. What challenges did you face?

When discussing a past project, focus on a specific example where you successfully developed test protocols. Highlight any challenges, such as adapting protocols to fit custom requirements or tight deadlines, and explain how you resolved them, showcasing your problem-solving skills and attention to detail.

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How do you ensure the high-quality documentation of commissioning and qualification at Cytiva?

To ensure high-quality documentation, it's important to articulate your approach to detailed record-keeping and adherence to established guidelines. Explain your methods for cross-checking documentation, simulating tests, and keeping lines of communication open with teams to maintain quality and compliance.

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What experience do you have with Quality Management Systems (QMS) and how has it prepared you for this role?

Discuss your experience working within QMS environments and how it has prepared you for the Qualification Services Systems Engineer role. Emphasize how understanding QMS principles helps you navigate the creation of qualification documentation effectively, ensuring all processes meet necessary standards.

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What strategies do you use to adapt test protocols for customer-specific requirements?

Share strategies you use to evaluate customer needs and adapt protocols accordingly. Highlight your ability to communicate with clients, comprehend their unique challenges, and implement tailored solutions to maintain project timelines and quality.

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How do you handle stress when managing multiple projects with tight deadlines?

In this response, focus on time management skills and how you prioritize tasks. Mention techniques such as breaking projects into manageable steps, using project management tools, and keeping open communication with team members to mitigate stress and ensure timely completion.

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Describe your experience working in a remote, global team. What challenges have you faced and how did you overcome them?

Discuss your experience working with remote teams, emphasizing communication, collaboration tools, and cultural sensitivity. Reflect on any challenges, such as time zone differences or communication gaps, and illustrate how you facilitated teamwork and ensured project goals were met.

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What role does simulation play in testing and qualification, from your perspective?

In your answer, explain how simulation is a critical component of testing and qualification processes. Discuss how it helps identify issues before equipment deployment, enhances confidence in the results, and contributes to overall quality assurance.

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What motivates you to work in the life sciences and diagnostics field

This question allows you to express your passion for the life sciences and diagnostics sector. Discuss your desire to contribute to meaningful innovations that save lives and how each project aligns with your personal and professional goals in making a difference.

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How would you approach training content updates for field service engineering teams?

Outline a systematic approach you would take to ensure training content is relevant and up-to-date. Mention the importance of feedback from field teams, the integration of recent experiences, and the necessity for continuous education in a constantly evolving technological landscape.

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Cytiva is a global biotechnology leader dedicated to helping customers discover and commercialize the next generation of therapeutics. We bring dedicated technical expertise and a broad portfolio of tools, technologies, and services that enable th...

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Full-time, on-site
DATE POSTED
April 13, 2025

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