IT Validation Manager - Paris, France - Cytiva

Cytiva
Cytiva
Entreprise vérifiée
Paris, France

il y a 3 semaines

Sophie Dupont

Posté par:

Sophie Dupont

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Description

Be part of something altogether life-changing

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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.

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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.

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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.

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What you'll do

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Partners with QA to simplify and optimize the validation processes

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Maintains and Updates the Validation and Test procedures, processes, templates, guidance and documentation as needed

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Delivers training in Validation and Testing best practice to Cytiva

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Works 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

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Provide guidance on validation approach for validation project team

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Mentors and supports the Validation and Test Engineers and contract resources to support projects as needed

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Supports change control process from Assess change control validation impact through closure including approval and authorization for move into production.

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Performs vendor audit and assessments as necessary

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Assess supplier qualification of regulated non-product software to determine Supplier Risk on Cytiva and disposition the supplier's adequacy.

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Evaluate the results of the assessment including mitigation of identified issues to determine regulated non-product software validation approach and deliverables

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Approve validation deliverables as required by Cytiva QMS, regulatory compliance and any specific validation plan requirement.

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Who you are

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Experience working with virtual teams on a global basis.

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FDA and regulatory compliance knowledge

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Strong communication skills in English

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Quality minded - must be focused on, and capable of, delivering high quality validation related contribution to the Cytiva IT function.

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It would be a plus if you also possess previous experience in

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Inclusiveness - demonstrated ability to work well within an IT Team and with people at all levels of the Cytiva and broader Danaher organization.

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Influencing/communication
  • Excellent influencing, interpersonal and communications skills (both written and verbal) with all levels of an organization.
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Logical thinking - can deal with ambiguity effectively in order to create logical, structured and credible validation plans/strategies.#LI-remote

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At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.

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Faites partie de quelque chose qui change complètement votre vie


Travailler chez Cytiva dans le secteur des sciences de la vie, c'est être à la pointe de la fourniture de nouvelles solutions pour transformer la santé humaine.

Nos incroyables clients entreprennent des activités vitales allant de la recherche biologique fondamentale au développement de vaccins innovants, de nouveaux médicaments et de thérapies cellulaires et géniques.


Chez Cytiva, vous serez en mesure de vous améliorer continuellement, ainsi que nous-mêmes, en travaillant sur des défis qui comptent vraiment avec des personnes qui prennent soin les unes des autres, de nos clients et de leurs patients.

Avec des associés dans 40 pays, Cytiva est un endroit où chaque jour est une opportunité d'apprentissage - afin que vous puissiez développer votre carrière et développer vos compétences sur le long terme.

Cytiva est fière de travailler aux côtés d'une communauté de neuf autres sociétés de Danaher Life Sciences.

Ensemble, nous ouvrons la voie à l'avenir de la science et de la médecine, en développant des produits qui permettent aux chercheurs de lutter pour sauver des vies.


Ce que vous ferez

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