Job title: Calibration Engineer

Location: Beijing Site

About the job

Sanofi has decided to invest into a new large state-of-the art facility for Insulin Drug Substance in Beijing, China. For this green field operation, we’re enhancing our legacy of excellence and build on decades of expertise on the whole value chain of insulin manufacturing. The new facility will be designed as a fully automated, green, modern, and state-of-the-art biologics facility. A large global and highly cross-functional program organization will be established to lead and execute the program until commercial routine manufacturing.

Meet Katrin, our Global Program Leader, and discover how we’re transforming insulin production. Watch now!

Main responsibilities

Collaborate to URS definition for calibration needs and ensure process parameter data are available (set point, ranges, resolution, tolerances…) during design phases. Ensure link with Frankfurt legacy plant Calibration SME to advise on some decision making and collect feedback for best integration.

• Design calibration strategy: Define registration process according to Sanofi Global standards (criticality assessment, maximum permissible error calculations…),

• Define execution process including labelling, certificates management, compliance status.

• Lead “blue reviews” based on P&ID and instrumentation documentation with process, MSAT, manufacturing and quality teams to validate compliance parameters.

• Build and deliver calibration plan with measuring chains inventory, compliance parameters and adapted control frequencies. This for instruments, laboratory equipment and technical checks activities (Environmental control in HVAC systems, thermal mapping…) Ensure implementation of stand-alone calibration software tool. for C&Q phase (initial calibration registration) and its migration to iShift program for routine (periodic calibration) mode with support of CMMS key-user.

• trajectoiTransfer and implement calibration plans with Beijing local maintenance team and to manage execution plan for initial controls with local resources

About you

List here ideally the must-haves criteria to be successful on the role.

Worked more than 5 years in technical positions in industrial sites, including at least one experience in Validation or Calibration engineer.Experience and knowledge of GMP, FDA, and EU guidelines and legal metrology guidelines.Experience in working in a large, complex matrixes environment with global processes and governance structures.Soft and technical skills:

- Rigorous, organized, factual and results-oriented.

- Good general technical knowledge, ability to interact with experts, especially instrumentation.

- Customer Centricity / Results oriented / Teamwork / Clear thinker.

- Act for innovation, initiating new and improved ways of working

Education: Master’s degree in industrial engineering domain: Process / Quality / Instrumentation, Generalist Engineer diploma.Languages: Chinese and Fluent in English (Project language),

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.Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention, and wellness programs.

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.
 

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

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But 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. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

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