V&V Engineer II

• 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.

  Learn about the Danaher Business System which makes everything possible.

  The V&V Engineer II is responsible leading multiple DK V&V projects, driving successful delivery of strategic initiatives, and fostering cross-functional collaboration to achieve business goals.

  This position reports to the Sr. Manager, V&V and is part of the Cell Therapy R&D Department located in Grens and will be an on-site role.

• What you will do:

• Define, write and execute V&V scope, plans, procedures, methods, tests and reports.

• Comply with sub-system requirements (DK-SSRS), regulatory requirements and QMS.

• Perform, assess and improve measurement equipment qualification and validation (e.g. IQ, OQ, TMV - Gage R&R).

• Support and execute product root cause analysis and investigations related to customer complaints, failures in manufacturing or V&V.

• Collaborate closely with System and DK Sub-System V&V Leads , Product Engineering Technical Leaders, Project Managers, Design Quality teams to ensure compliance and robustness of V&V.

• Support new products development and legacy products sustaining with V&V managed to the highest quality standards as per our QMS.

• Adopt the Danaher Business System (DBS).

• Who you are:

• Bachelor's or Master's degree in a relevant scientific or engineering discipline (e.g., mechanical, electrical, materials, systems, industrial, biomedical).

• Minimum 6+ years of experience leading V&V projects, with a proven ability to deliver on time and within budget while meeting quality and performance requirements.

• Experience across the full product lifecycle including design, development, verification, validation, and manufacturing of mechano-fluidic or equivalent products within regulated industries (e.g. pharmaceutical, medical device, combination product). Knowledge and practical experience of relevant regulations and standards (ISO13485, ISO 9001, FDA 21 CFR Part 820).

• Passionate about working in a cross-functional organization.

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.

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