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Danaher Corporation Validation Engineer in Logan, Utah

Be part of something altogether life-changing!

Working at Cytiva in the Life Sciences industry 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.

Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.

What you’ll do

  • Quality engineers are responsible for coordination and execution of validation studies in accordance with current Good Manufacturing Practices. Essential responsibilities include:

  • Lead analysis of defect data and CAPA creation / resolution and maintain records as specified by the Cytiva quality system.

  • Interface with Supplier Quality on supplier related defects.

  • Perform Validation for implementation of major and minor software and equipment applications or modules for Good Manufacturing Practices (GMP) use.

  • Write and conduct computer/equipment system/software validations (IQ/OQ/PQ) for manufacturing processes and equipment.

  • Maintain regular contact with customers to ensure products meet expectations.

  • Conduct root cause analysis on product quality issues, identify trends, and communicate with other functional departments for resolution.

  • Reduction of MRB and non-conforming material inventory.

  • Develop, establish, and optimize quality inspection methods, test methods, and product specifications.

  • Ensure compliance through validation and verification (V&V).

Who you are

  • Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 5 years of experience in ISO13485 Manufacturing).

  • Familiar with Quality Systems Regulations (such as FDA 21CFR820 & 21CFR210) and International Quality System Standards (like ISO13485).

  • Strong working knowledge of computer programming and systems (Gamp5 or similar).

  • Understanding of computer logic.

  • Strong communication skills, verbal and written.

  • Working knowledge of Excel, Word, Power Point, Minitab, Statistica.

  • Ability to read and understand CAD drawings.

  • Some traveling may be required (less than 10% of time).

Desired Characteristics

  • Bachelor’s degree in engineering or science related field

  • 3 years of quality assurance or quality engineering experience

  • Green Belt Certified

  • CQE Certification

  • Knowledge of 5S and Lean Manufacturing experience

  • Strong working knowledge of Current Good Manufacturing Practices (cGMP)

  • Demonstrated ability to lead

  • Process management skills

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.

Danaher is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.

If you’ve ever wondered what’s within you, there’s no better time to find out!

Individuals who need a reasonable accommodation because of a disability for any part of the employment process should call 202-419-7762 or e-mail applyassistance@danaher.com to request accommodation. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.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 (https://www.dol.gov/agencies/ofccp/posters) .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 202.419.7762 or applyassistance@danaher.com to request accommodation.If you’ve ever wondered what’s within you, there’s no better time to find out.

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