C&Q Project Leader(all genders)

at  Sanofi US

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.

• 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.