Commissioning & Qualification Leader

Sanofi US; Lyon; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A global biopharma company in Lyon seeks an experienced C&Q Leader to develop and implement C&Q strategies, lead project teams, and ensure compliance with regulatory standards. The ideal candidate has 10 years of experience in the pharmaceutical industry, speaks fluent French and English, and possesses strong communication skills. Join us to contribute towards innovative solutions that improve people's lives.

Qualifications

• 10 years of experience in Commissioning and Qualification or Engineering projects in the pharmaceutical industry.
• Significant experiences as C&Q Lead for various investment projects.
• Ability to influence and build relationships across organizations.

Responsabilités

• Develop and lead the project C&Q team and ensure appropriate C&Q training.
• Execute the project's C&Q strategy on the Neuville site.
• Collaborate closely with the Modulus Project Manager for project organization.

Connaissances

Fluent in French

Fluent in English

Team management

Communication skills

Understanding of regulatory standards

Formation

Bachelor of Applied Science and Engineering

Description du poste

Job title: C&Q Leader

Location: Neuville, Carteret

Job type: Permanent

About the job

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 ecosystem (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.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com.