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
R&D Technical Lead - Associate Senior V&V Engineer
is responsible for leading multiple System 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
* Lead/Principal System V&V development and execution including scope, strategy, plans, procedures, methods, traceability matrices and reports.
* Collaborate closely with System Engineering, Product Managers, Project Managers and Product Engineering (technical leaders and extended team) to ensure all relevant system interfaces are considered and that the system functions effectively as a whole.
* Collaborate with cross-functional departments to ensure project success and customer satisfaction.
* Mentor Sub-System V&V Engineers to ensure all interfaces have been considered in V&V.
* Support new products development and legacy products sustaining with systemic V&V managed to the highest quality standards as per our QMS.
* Comply with system and sub-system requirements (URS, SRS, SSRS) to meet relevant regulatory standards and customers' expectations.
* Works with System Engineering, Product Managers, Project Managers and Product Engineering (technical leaders and extended team) to address and define way forward when gaps are identified in requirements, procedures, methods pertaining to development and V&V.
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 15+ years of experience leading complex V&V projects, with a proven ability to deliver on time and within budget while meeting quality and performance requirements.
* Experience with system V&V 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).
* Work independently to define ambiguous projects and clarify scope, specifications and deliverables. Passionate about mentoring and coaching team members to support their professional growth and continuous development.
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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