IT Validation Manager and Continuous Improvement Leader

Job content

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

Be acknowledged as a subject matter expert in Computer Systems Validation (CSV) management, with specific expertise in best practice and how to implement this within Cytiva. Has a thorough knowledge of how the discipline contributes to broader Cytiva Risk & Compliance strategy and an understanding of the Quality and regulatory compliance. Can make complex judgements based on analytical thought and interpretative thinking in order to develop innovative solutions. Will lead and manage Validation and Test engineers to support multiple projects.

• Acts as the Operational Excellence Leader for Cytiva in CSV. Partnering with QA to simplify and optimize the validation processes
• Delivers training in Validation best practice to Cytiva
• Maintains and Updates the validation procedures, processes, templates, guidance and documentation as needed
• Performs vendor audit and assessments as necessary
• CAB and Design Authority CSV member
• Mentors and manages Validation Engineers and contract resources to support projects as needed
• Assess supplier qualification of regulated non-product software to determine Supplier Risk on Cytiva and disposition the supplier’s adequacy
• Evaluate the results of the assessment including mitigation of identified issues to determine regulated non-product software validation approach and deliverables
• Approve validation deliverables as required by Cytiva QMS, regulatory compliance and any specific validation plan requirement
  

Who You Are

• Degree Educates with a STEM subject, with a minimum 5 years’ experience in Information Technology and Risk & Compliance but typically 7+ years. (Experience in place of Degree is considered)
• Experience working with virtual teams on a global basis.
• FDA and regulatory compliance knowledge
• Strong communication skills in English
• Leadership of teams is desirable
• Quality minded - must be focused on, and capable of, delivering high quality validation related contribution to the Cytiva IT function
• Inclusiveness - demonstrated ability to work well within an IT Validation Team and with people at all levels of the Cytiva and broader Danaher organization
• Influencing/communication - Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization
• Logical thinking – can deal with ambiguity effectively in order to create logical, structured and credible validation plans/strategies
• Pragmatism/creativity - Is passionate about validation and the value it brings / role it plays in IT and is able to think creatively and pragmatically in order to ensure that value is applied in the most effective way
  

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 tools and the stability of a tested organization.

At Danaher, 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.

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