IT Validation Manager

☞ Cytiva

View: 207

Update day: 20-03-2024

Location: Mellingen Aargau AG

Category: IT - Software

Industry: Medical Equipment Biotechnology Research Pharmaceutical Manufacturing

Job type: Full-time

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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.

We are looking for a ITValidation Manager to work with our expert Information Technology team across the world. Do you have a passion for computer systems validation management? Then we would love to hear from you.

What You’ll Do

Is acknowledged as a subject matter expert in computer systems validation management, with specific expertise in how that relates to one or more IT functional areas of the Cytiva business; is an expert in discipline within the function(s). Has a thorough knowledge of how the discipline contributes to broader Cytiva Risk & Compliance strategy and an understanding of the competitive landscape in the Risk & Compliance field. Can make complex judgements based on analytical thought and interpretative thinking in order to develop innovative solutions.
  • Work with project stakeholders and QA to develop regulated non-product software Validation Plans defining the approach to perform the required validation activities, the list of deliverables, acceptance criteria and support processes required.
  • Provide guidance on validation approach for validation project team.
  • 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.
  • Support change control process from Assess change control validation impact through closure including approval and authorization for move into production.
  • Partner with QA to develop any specific work instructions required to support validation activities whether associated or not with software used to support validation activities.
  • Work with IT Validation Team and IT Management to ensure validation demand is prioritized and acted upon in the most efficient way possible, without compromising compliance or quality.
  • Capable of leading a small number of ‘Validation on Demand’ contract resources, providing capacity at times of peak validation demand.
  • Communicates solutions, validation status with cross functional partner organizations.
Who You Are
  • Minimum 5 years’ experience in Information Technology and Risk & Compliance but typically 7+ years.
  • Experience working with virtual teams on a global basis.
  • FDA and regulatory compliance knowledge.
  • Strong communication skills in English.
  • 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 a 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.
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Deadline: 04-05-2024

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