SANOFI : COMMISSIONING & QUALIFICATION LEADER (H/F)

Poste
Niveau d'étude
Activités de l'entreprise
,
Localisation
Neuville-sur-Saône (69, Rhone)

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Présentation

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

This job offer is accessible to all, regardless of gender.

Job title: C&Q Leader

  • Location: Neuville, Carteret
  • Job type: Permanent

About the job

About Sanofi:

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Our Team:

Within Global Engineering, France Project Delivery delivers capital projects by performing engineering studies and execution for Tiers 1 & 2 Projects & Programs related to French M&S sites, with the support of all engineering eco system (project controls, automation, site engineering) and relevant stakeholders.

The CQV team for France will define and implement C&Q Strategies to support clusters as well on project Design, Execution and other tasks like peers & gate reviews.

Main responsibilities:

The responsibilities of the job are focused on the Modulus (EVF) project and its next future related projects that will trigger new Global Engineering C&Q strategies to define and implement.

Execute the project's C&Q strategy on the Neuville sur Saône site, until the closure of all C&Q activities and deliverables under the Global Engineering scope (non-product dependent PQ and Turn-Over Packages) . Develop and lead the project C&Q team, ensuring appropriate C&Q training, expertise and delivery. Ensure periodic reporting on C&Q progress.

Define new project C&Q strategy to accommodate new processes within the Modulus building in accordance with external and internal regulatory and industrial requirements applicable to the Neuville site:

  • Update the project C&Q plan and system-specific validation plans. Contribute to the development of the project validation master plan
  • Contribute to the development of the C&Q schedule, performance indicators, monitoring tools, resource plan and specific training activities

Develop the strategy to maintain Modulus building systems qualified:

  • Establish a program for the periodic requalification of systems
  • Define the requalification strategy following changes in the specific EVF context
  • Develop the specific KNEAT templates and procedures, as necessary

Interact with the legacy part of Neuville's site to:

  • Ensure that the systems are properly overtaken by the site's support departments (Maintenance, Metrology, etc.)
  • Facilitate the transfer of knowledge and responsibility to the final user at the end of the project

More generally:

  • Ensure that standards (e.g. Engineering, EHS, Quality) in relation to CQV activities are implemented & validated before execution with a focus on design to cost solutions
  • Ensure that digital core model tools (e.g. KNEAT) are implemented for the projects
  • Collaborate closely with Modulus Project Manager to identify the appropriate staffing for the project organization to ensure all CQV key competencies are available
  • Ensure optimized C&Q solutions for equipment, systems and facilities
  • Ensure anticipation of project risks, tracking of action plans & communication on & across the site to manage risk all along the project
  • Ensure Sanofi signature for protocols, reports

About you

  • Bachelor of Applied Science and Engineering, Professional Engineer, 10 years of experience in Commissioning and Qualification and/or Engineering projects in pharmaceutical industry, preferably injectables and/or biologics products
  • Fluent in French and English spoken and written compulsory
  • Deep knowledge in pharmaceutical and industry regulations and standards associated with C&Q and Engineering
  • Significant experiences as C&Q Lead of various sizes of investment projects, including large projects. Competencies for managing a team and managing transversal interfaces, and taking the lead
  • Good relationships and communication skills to collaborate effectively with peers, stakeholders, partners across the organization, thus impacting positively business results
  • Ability to influence and build relationships across the organization Customer centricity/results oriented/teamwork/clear thinker/lean oriented

Pursue Progress. Discover Extraordinary

Join Sanofi and step into a new era of science - where your growth can be just as transformative as the work we do. We invest in you to reach further, think faster, and do what’s never-been-done-before. You’ll help push boundaries, challenge convention, and build smarter solutions that reach the communities we serve. Ready to chase the miracles of science and improve people’s lives? Let’s Pursue Progress and Discover Extraordinary – together.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity, protected veteran status or other characteristics protected by law.

#LI-FRA

#LI-Onsite

La diversité et l’inclusion sont les piliers de la manière dont Sanofi fonctionne et font partie intégrante des valeurs de la société. Nous respectons la diversité de nos collaborateurs, tout comme celle de leurs parcours et expériences. Afin de bénéficier de la richesse qu’apporte la diversité, Sanofi s’engage à donner l’exemple en matière d’inclusion et à favoriser un environnement de travail où les différences peuvent prospérer et contribuer à aider les patients à retrouver une vie meilleure.

Dans le cadre de son engagement diversité, Sanofi accueille et intègre des collaborateurs en situation de handicap.