Job title:C&Q Leader

• Location: Neuville, Carteret
• Job type: Permanent

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 organizationCustomer centricity/results oriented/teamwork/clear thinker/lean oriented

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