C&Q Project Leader(all genders)

About the job

Are you ready to jump into a mega project > 2 B€ Capex program to bring in your experience & knowledge and lead a team of up to 50 peaople?

The race is on to design & build our new Insulin flex facilities addressing BLA (Biologics License Application) . Your skills could be critical in helping us to design & build Organization & key processes to ensure robust start-up & routine operations.

You will lead all Commissioning & Qualifications activities for the program in accordance with Quality, regulations to build a first in class Insulin multi- insulins facility & a replication for Glargine in China.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

We are an innovative global healthcare company with a focus on immunology that extends to innovation in diabetes and transplant medicine. Across different countries, our talented teams are determined to deliver a best-in-class customer experience using the best of digital, artificial intelligence and personal know-how. With a focus on immunology that extends to innovation in diabetes and transplant medicines, we pursue progress to make a real impact on millions of patients around the world.

Main missions

• The C&Q Lead provides technical experience, expertise & oversight to ensure full traceability of all deliverables from design to handover to guarantee a successful start-up.

• This position is accountable to provide input on all C&Q based activities (schedule, budget, resources & quality) from construction through to successful technical run execution, ensuring compliance with corporate and regulatory guidelines.

Main responsibilities

• Implement a risk-based validation strategy for a new manufacturing facility and associated critical utilities and equipment.

• Lead activities from document preparation through execution and handover to system owners.

• Build & manage an efficient C&Q team to lead cross-function execution workstreams.

• Manage interface between project engineering functions (CM, process engineering, automation, C&Q) to optimize project timelines and drive results.

• Ensure adequate schedule, budget, resources & risks monitoring.

• Assure User Requirement Specifications (URS) and Compliance requirements are met as planned.

• Manage SLA, FCCA, FAT & Critical test plan.

• Contribute within the Global engineering network to lessons learned.

• Ensure GxP deliverables are met according to Validation Master Plan, URS & RTM.

• Review and assess impact of changes to the qualification status of process system/equipment and facility systems using appropriate SOPs.

• Coordinate construction walk-throughs & punch list.

• Develop and implement qualification protocols as required by the Validation Master Plan.

• Audit project documentation for turnover to the customer to ensure compliance.

• Establish and maintain a Startup Documentation Library.

About you

• Experience: strong direct experience in applied execution C&Q and major capital project experience are required; additional experience in construction/installation, equipment start-up or validation is mandatory

• Soft and technical skills: strong knowledge of computer software validation (CSV); In depth knowledge in Biologics processes including aseptic technologies; must be able to apply a risk-based approach; collaborate effectively with peers, stakeholders, partners across the organization to positively impact project results; develop teams in anticipation of future project needs; act for innovation, initiating new and improved ways of working; ability to translate business needs into technical requirements; develop Performance through pragmatic approach

• Education: master’s degree in chemical or biotech process engineering

• Languages: excellent communication skills (written and oral) in english; additional languages will be appreciated

Why choose us ?

• Play an instrumental part in creating best practice within our manufacturing facility.

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Pursue Progress. Discover Extraordinary.

Progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s 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, or gender.

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