Role at a glance
- Job function
-
Manufacturing & Skilled Trades Manufacturing & Production
- Salary
- Not Disclosed
- Location
- Beijing
- Employment
- Full-time
- Experience
- More than 2 years of industrial experience in the pharmaceutical environment with a strong focus on the manufacture of insulins,...
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Role Summary
The Operation Experts support workstreams for the design, construction, and commissioning of Sanofi’s new insulin production facility in Beijing, and the transfer of products into routine production. They represent operational expertise and work with Engineering and other project partners across facility and process development.
What You'll Do
- Represent workstream operational knowledge within the project team.
- Support project activities including planning and design, P&ID review, HAZOP, functional design, URS authoring, and technical...
- Partner with Engineering on process and clean-utilities requirements, equipment and system designs, and operational documentation.
- Support equipment and system commissioning and ensure the technical design is fulfilled and consistent with IFF.
- Coordinate digital solution implementation, including MES and DCS.
- Support OQ/PQ/PPQ execution and collaborate with MSAT on technology transfer and scale-up.
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View full postingQualifications
Requires more than 2 years of pharmaceutical industrial experience focused on manufacturing insulins, biologics, or other pharmaceutical substances, cGMP knowledge, and either a relevant bachelor's degree or a Technician/Master Craftsman qualification with many years of pharmaceutical production experience. Also requires English speaking and writing skills, teamwork and communication, leadership, and the ability to work under pressure in a matrix-driven project environment and collaborate across functions. Willingness to travel to Germany for knowledge transfer is required.
Preferred
- Technical background in insulin manufacturing is a plus.
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Background
Sanofi has decided to invest in new, state-of-the-art production facilities for the entire insulin portfolio as part of the InsuLINK program, to ensure a future-oriented, sustainable, and reliable long-term supply for diabetes patients worldwide.
Beijing, China (IFB = Insulin Facility Beijing) and Frankfurt, Germany (IFF = Insulin Facility Frankfurt) have been selected as the locations for the two facilities.
The new production facilities will be designed as fully automated, environmentally friendly, and state-of-the-art biologics facilities that consider the specific process requirements of all insulins.
Position Overview
We are looking for 4 Operation Experts for the workstreams "Upstream" and "Downstream" for the following focus areas:
- USP: Upstream / Fermentation
- MSP: Midstream / Cell harvest to Bag filter
- DSP: Downstream I / High Purification, Chromatography
- DSP: Downstream II / Isolation and Drying
They will report to the respective department heads of USP, MSP, DSP I and DSP II.
These positions play a crucial role in the design, planning, construction, and commissioning of our new state-of-the-art insulin production facility in Beijing, as well as the product transfer into routine production.
The successful candidates will work within the Operations unit in close partnership with the Engineering teams to help shape the success of this project.
Responsibilities
- Represents the know-how and operational knowledge of their workstreams within the project team
- Supports the project tasks of their teams in various phases of the engineering/construction project, e.g., planning and design, P&ID review, HAZOP, functional design, author the URS and lead the technical clarification with Frankfurt.
- Partnership and collaboration with Engineering on various project topics:
- Creation of process-relevant and clean utilities user requirements
- Equipment and system designs
- Development of Standard Operating Procedures (SOPs) and operational documentation
- Commissioning of equipment and systems
- Lead to ensure technical design is fulfilled and consistent with IFF.
- Coordinate within responsible steps for digital solution implementation, such as MES, DCS etc.
- Ensure in OQ/PQ/PPQ execution for the manufacture of insulin
- Partnership with MSAT in technology transfer and scale-up activities, efficient collaboration in highly cross-functional teams
About You
Experience
- Bachelor’s degree in chemical engineering, Biotechnology, Bioengineering, or a related field
- Alternatively, qualification as a Technician/Master Craftsman with many years of experience in a production environment in pharmaceutical manufacturing
- More than 2 years of industrial experience in the pharmaceutical environment with a strong focus on the manufacture of insulins, biologics or other pharmaceutical substances
- cGMP knowledge
- Technical background in insulin manufacturing is a plus
Skills
- Ability to work under high pressure in a constantly changing project environment
- Ability to work in a highly matrix-driven project environment with strong functional reporting lines
- Leadership skills for both functional and directly reporting teams
- Excellent teamwork and communication skills
- Ability to collaborate closely and build cross-functional bridges
- Willingness to travel to Germany for knowledge transfer
- English language skills in both speaking and writing
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!
About the company
Sanofi
Large Enterprise
Sanofi is a global healthcare leader committed to promoting health and well-being through the development of innovative medicines, vaccines, and therapeutic solutions. With a diverse portfolio that spans multiple therapeutic areas, including diabetes, oncology, and immunology, Sanofi is dedicated to addressing pressing health challenges and improving patient outcomes worldwide. Headquartered in France, the company employs over 100,000 individuals across more than 100 countries, fostering a culture of collaboration and scientific excellence to drive advancements in healthcare.