M&S-IFB Commissioning & Qualification Lead-Beijing

IFB Commissioning & Qualification Lead

About the job

Are you ready to jump into a mega project (> 1 B€ Capex program, thereof design/engineering budget

>>200 m€), and to bring in your experience & knowledge ? The race is on to design & build our new Insulin flex facility in Beijing addressing capacity increase demand.

Your skills could be critical in helping us to achieve our key project milestones. You will lead all Commissioning and Qualification activities from Basic Engineering until end of Qualification activities in accordance with EHS, Quality, Engineering, Business & Users requirements standard and expectations. Within the greenfield IFB (insulin Beijing Facility) project team, and part of our InsuLINK program for insulin drug substance facilities.

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.

Main responsibilities:

• To lead the IFB C&Q team (system leaders, per workstream / group of systems).

• To design C&Q detailed approach for IFB, based on endorsed InsuLINK strategy as per C&Q project plan, for all systems (GxP and non-GxP).

• To coordinate the Sanofi C&Q work with the EPCMCQ engineering contractor for C&Q topic and all disciplines withing Sanofi IFB organization. And with InsuLINK C&Q Leader.

• To ensure all C&Q documents are on time with Sanofi / EPCMCQ contractor, including FAT/SAT documents.

• To author URS as per schedule.

• To deliver C&Q activities and qualification report on time.

• To lead and manage deviation process and ensure deviation are closed on time with all expected documents, with no impact on schedule L2.

• To provide support to project change, engineering change and technical change assessment with regards to C&Q part.

• To prepare transition after OQ/PQ with MSAT and Operations.

• To collaborate to project meeting.

About you

Experience:

• Several years of professional experience in managing teams (direct and indirect) in the pharmaceutical industry

• Strong experience of pharmaceutical facility start-up and commissioning

• Very good knowledge of commissioning and qualification in active pharmaceutical ingredient production environment, greenfield/brownfiled project and/or operational facility

• Proven multi-year experience (>10 years) in the area of project and engineering management

• Experience in working in a large, complex matrixes environment with global processes and governance structures.

Soft skills:

• Very good communication and presentation skills

• Systematic and structured work style

• Result oriented and pragmatic

Technical skills:

• Good knowledge of FDA/China and other regulatory requirements such as cGMP

• Strong knowledge and experience in performing facility / equipment / utility commissioning and/or qualification, including automated and computerized system.

• Good general technical knowledge, ability to interact with experts

Education:

• Good general technical knowledge, ability to interact with experts

Languages:

• Good general technical knowledge, ability to interact with experts

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 identity.