16/10/2025

17:30 – 18:30 CST

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Sanofi’s new Beijing insulin facility is more than a state-of-the-art site – it’s part of a bold global project that brings 100 years of insulin expertise into a new era of innovation, digitalization, and sustainability. Designed to meet the highest standards for biologics production, this facility sets a new benchmark for advanced Bio-Manufacturing in China.

For future talents in Manufacturing, Engineering and Quality, its also a unique career opportunity. By joining this journey, you’ll gain access to cutting-edge technology, collaborate with experts from around the world, and build future-ready skills that can shape your career and make a difference for millions of people living with diabetes.

This jobinar is your chance to hear directly from Sanofi leaders, explore the vision behind InsuLINK, and learn how you can be part of a team that’s transforming healthcare – right here in Beijing.

Meet the speakers

Katrin Lehmann-Barlen
End to End Strategic Facilities Program Head
Alex Bolbocianu
Head of IFB Project
Jane Zhang
Head IFB Operations
Yulin Wang
Quality Control Lead IFB

Audrey Clegg

Chief Talent & Learning Officer

Fei Fang

Talent Acquisition Partner, IFB

Sanofi is an R&D-driven, AI-powered biopharma company committed to improving lives and driving sustainable growth. In China, our second-largest market and a key strategic priority, we integrate global innovation with local expertise to deliver breakthrough solutions that matter most to patients.

We’ve built a full value chain here – from R&D to manufacturing and commercial operations – supported by four R&D centers and three manufacturing sites. Our €1 billion insulin facility in Beijing reflects our ambition to move from “Made in China” to “Innovated in China,” strengthening local impact while upholding Sanofi’s global insulin legacy.

By leveraging AI and strong local collaborations, we accelerate access to innovative treatments, particularly in immunology. Committed to sustainability and public health, we drive educational programs, reinforce healthcare system resilience, and aim for carbon neutrality by 2030.

Sanofi China continues to shape the future of healthcare – turning innovation into solutions, expanding access to care, and creating a healthier, more sustainable future.

Explore More – Change Expands Opportunity

Give: An eagerness to learn and a desire to always improve.
Get: Exciting opportunities to upskill, reskill and deepen expertise.

Chase Change – Care and Integrity in Action

Give: A desire to challenge what’s gone before and embrace change.
Get: The ability to work with pioneering technologies and invent the new.

Do Right – Embrace and Advance

Give: A focus on doing right for patients and a willingness to share across borders.
Get: A locally focused, safe working environment.

Make Miracles – A Vital Contribution

Give: A high standard of performance and willingness to go the extra mile.
Get: The pride that comes with being at the heart of helping millions of patients.

Commissioning & Qualification Lead

Location: Bejing

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:

  • Engineer (Diploma, Master, or Ph.D.), Process Engineering, Biotechnology Engineering, Mechanical Engineering, Automation/Process control Engineering or Medical Engineering

Languages:

  • Chinese (fluent), very good English language skills, both written and verbal
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.

CC & MQC Lead

Location: Bejing

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.

Main responsibilities

The CC & MQC Project Lead IFB (Contamination Control and Microbiological Control, Insulin facility Beijing) is responsible for ensuring that all aspects of Contamination Control and microbiological Quality Control across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval. The position will hold overall responsibility for the successful delivery of all Contamination Control and microbiological Quality Control of the project in China, including regulatory approval and transition to commercial production.

As an integral part of the project quality team, this position has overall accountability for the functions of Contamination Control and microbiological Quality Control in China. Assurance of a sustainable compliance of the project and future site with legal and quality requirements by continuous consideration of further and new developments in regulatory requirements. Assurance of the most effective use of the available resources for contamination control and microbiological quality control based on SMS 2.0 principles, leading/participating in project workstreams, ensuring proper execution of C&Q&V strategies as well as providing support and guidance for contamination control and microbiological quality control processes and procedures.

This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval.

Management:

  • Is responsible of the delivery of all the IFB contamination control and microbiological quality control aspects of the project, within the allocated budget, project schedule and the expected objectives.
  • Builds and manages the IFB contamination control and microbiological quality control project team consisting of internal and external experts.
  • Ensures the project is performed according to the Sanofi Standards and Good Practices.
  • Ensures regular reporting to the Global Quality Program Lead.
  • Ensures strategic workforce planning of the CC & MQC organization during both project and routine manufacturing modes.
  • Develops strategic and operational synergies with the existing Beijing DP site.
  • Works with existing Frankfurt organization and global SME network.

Commissioning & Qualification and Validation:

  • Ensures development, implementation and assurance of CC & MQC in IFB.
  • Defines and oversees the project C&Q&V strategy, C&Q&V plans and System impact assessment.
  • Ensures the preparation and the execution of DQ, SAT, FAT, IQ, OQ and nP-PQ protocols, final CQ reports and VMP.
  • Interacts with the IFF (Insulin Frankfurt Facility) to keep benchmark and best practices cross-fertilization.
  • Responsible for the consistency of the turnover package to system owners.

Project Control, Cost & Schedule:

  • Responsible for the IFB CC & MQC budget and schedule.
  • Responsible for the regular collection of actual contamination control and microbiological quality control cost and progress.
  • Responsible for the project compliance with Sanofi Cost & Schedule Policies and Standard.
  • Contributing to decision making process regarding Cost & Schedule optimization.
 About you

Experience

  • 8 years industry experience, preferably within the biopharma and/or Microbiological Quality Control at an industrial (Pharma or food is preferred) site.
  • Minimum of +5yrs in Leadership position with a proven track record of delivery and compliance.
  • I’ll help you integrate the GxP and health-related regulations text into the existing content. Let
  • Knowledge & experience in Commissioning & Qualification, Process Validation Lifecycle, Quality by Design principles, transversal validations activities, as well as Pharmaceutical Manufacturing with production processing including automation, GxP and health-related regulations including Annex 1 knowledge in production and development of active substances and drug product (e.g. Steriles, Vaccines and Biotechnology), scientific writing, effective oral and written communication skills, and innovative thinking. Familiarity with strategic planning, balanced judgment and risk analysis.
  • Experience working on large capex projects in Asia (China, Singapore, etc) is a strong asset.

Soft skills

  • Collaborate effectively with peers, stakeholders, partners across the organization to positively impact business results.
  • Act for innovation, initiating new and improved ways of working.
  • Develop teams in anticipation of future business needs.
  • LEAN oriented, problem solving & new way of working.
  • Open minded and curios to learn new tools.

Technical skills

  • In-depth knowledge of the biologic product license application process, and the associated regulatory requirements.
  • Know-how in Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure, KNEAT solution is a plus.

Education

  • Degree in Biology/Microbiology/Pharmacy or Equivalent.
  • Ideally MSc or PhD level qualification in Science.

Languages

  • Excellent communication skills (written and oral) in English
  • Chinese (Mandarin) is a strong asset.
Why choose us?
  • 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 and at least 14 weeks’ gender-neutral parental leave.
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.

Upstream Process Engineer

Location: Bejing

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.

Main responsibilities
  • Collaborate strongly with IFF Program teams to Manage all Upstream Process Engineering activities (large volume bioreactor up to enzymatic folding and cleavage) from Basic Engineering to Detailed Design studies with optimized solutions leveraging Frankfurt process replication while integrating China local rules & codes.
  • Define together with Purchasing, Global SME and Program Design Team the best contract model for Process Engineering: Equipment order, Design, Construction.
  • Collaborate with transversal functions (EHS, Operations & Quality, procurement, legal and others) to manage basic engineering & Detailed Design studies with optimized solutions
  • Deliver design on time in full & reach project objectives (User Requirement Specification, Layout, Design Specification, Piping & Instrumentation Diagram, Functional analysis for process control & supervision, …) in accordance with EHS, Quality, Business & Users requirements focus on design to cost solutions
  • Risk Management: Anticipate, identify, and manage project risks by creating and tracking action plans, and communication to Process lead.
  • Build and sustain high performance team (internal & external)
  • Provide technical support for commissioning (FAT/SAT), Startup / C&Q activities in close collaboration with the C&Q leader
 About you
  • Experience in Pharmaceutical Process Engineering Tier 1 project > 50 m€
  • Soft and technical skills: 
    • Experience in managing Engineering contracts & facility start-up
    • In depth knowledge in Chemistry processes including aseptic technologies
    • Excellent problem solver and able to generate innovative digital solutions to improve efficiency
    • Collaborate effectively across the organization and build strong relationships to positively impact project results
    • Develop teams for future needs and translate business requirements into technical solutions
  • Education: Master’s degree in Chemical or Biotech Process Engineering
  • Languages:  Chinese (Mandarin), Excellent communication skills (written and oral) in English (Project language)
Why choose us?
  • 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 and at least 14 weeks’ gender-neutral parental leave.
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.

Manufacturing System Lead

Location: Bejing

Ready to push the limits of what’s possible?
Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

As an Automation Lead for EMS/BMS Systems within the Insulin Factory Beijing (IFB) project and part of our Global Manufacturing Systems & Automation team, you will be responsible for the planning, integration, and delivery of automation solutions for building and environmental monitoring systems. You will report to the Automation Project Lead and work at the interface of facility systems, GMP compliance, and digital manufacturing.

Main responsibilities
  • Lead the end-to-end automation scope for EMS and BMS systems within the IFB project, ensuring timely and compliant project execution in line with cost, schedule, and quality targets.
  • Define and manage system architecture and interfaces between EMS/BMS and related systems (HVAC, cleanroom/Storage monitoring, SCADA, PCS/DCS, Data Historian, Utility, and MES).
  • Ensure EMS/BMS systems support GMP-critical monitoring (e.g., temperature, humidity, differential pressure, particle counts), facility control (e.g., AHU, lighting, access), and integration with alarm management.
  • Act as the primary point of contact for internal stakeholders (QA, CQV, CSV, Engineering, HSE, ITS) and external suppliers for EMS/BMS topics.
  • Support and supervise commissioning and qualification activities (e.g., AIV/ACO), including integration testing and functional verifications of GMP-critical systems.
  • Drive compliance with computerized systems validation (CSV) and data integrity (DI) standards as per GAMP5 and current regulatory expectations.
  • Provide and maintain comprehensive documentation such as User Requirement Specifications (URS), Functional Specifications (FS), and risk assessments.
  • Enable connectivity between EMS/BMS and digital platforms to facilitate advanced monitoring, predictive maintenance, and energy optimization.
 About you
  • Degree in Automation, Building Technology, or related engineering discipline
  • Experience in delivering EMS/BMS systems in GMP-regulated pharma or biotech projects
  • Strong technical knowledge of building automation (e.g., Siemens Desigo, Honeywell, Johnson Controls, Schneider Electric, or similar)
  • Familiar with GxP-compliant HVAC/cleanroom systems and critical environmental monitoring
  • Proficient in CSV, GAMP5, and data integrity frameworks
  • Excellent project coordination and stakeholder management skills
  • Fluent in English; knowledge of Chinese or other languages is a plus
Why choose us?
  • Innovative environment: Work with cutting-edge automation and digital transformation technologies.
  • Career growth: Develop skills in a dynamic and evolving field with ample opportunities for progression.
  • Impactful work: Play a crucial role in enhancing operational efficiency and digitalization in insulin production.
  • At Sanofi, we celebrate diversity and inclusion, ensuring equal opportunities for all. Join us as we pursue progress and discover extraordinary together!

Lead groundbreaking automation within the IFB project in a supportive and innovative team, shaping the path to manufacturing and supply excellence for insulin production at Sanofi. This role is critical to our team’s success and offers exposure to a broad range of activities. For an ambitious automation engineer, it’s a chance to gain a lot of experience quickly.

Anthony Le Marre, Global Head of Manufacturing systems & Automation

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.

Downstream Process Engineer

Location: Bejing

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.

Main responsibilities

  • Collaborate strongly with IFF Program teams to Manage all Downstream Process Engineering activities (Chromatography, buffer hold, centrifuge / dryer, …) from Basic Engineering to Detailed Design studies with optimized solutions leveraging Frankfurt process replication while integrating China local rules & codes.
  • Define together with Purchasing, Global SME and Program Design Team the best contract model for Process Engineering: Equipment order, Design, Construction.
  • Collaborate with transversal functions (EHS, Operations & Quality, procurement, legal and others) to manage basic engineering & Detailed Design studies with optimized solutions
  • Deliver design on time in full & reach project objectives (User Requirement Specification, Layout, Design Specification, Piping & Instrumentation Diagram, Functional analysis for process control & supervision, …) in accordance with EHS, Quality, Business & Users requirements focus on design to cost solutions
  • Risk Management: Anticipate, identify, and manage project risks by creating and tracking action plans, and communication to Process lead.
  • Build and sustain high performance team (internal & external)
  • Provide technical support for commissioning (FAT/SAT), Startup / C&Q activities in close collaboration with the C&Q leader
 About you
  • Experience in Pharmaceutical Process Engineering Tier 1 project > 50 m€
  • Soft and technical skills: 
    • Experience in managing Engineering contracts & facility start-up
    • In depth knowledge in Chemistry processes including aseptic technologies
    • Excellent problem solver and able to generate innovative digital solutions to improve efficiency
    • Collaborate effectively across the organization and build strong relationships to positively impact project results
    • Develop teams for future needs and translate business requirements into technical solutions
  • Education: Master’s degree in Chemical or Biotech Process Engineering
  • Languages: Chinese (Mandarin), Excellent communication skills (written and oral) in English (Project language)
  •  
Why choose us?
  • 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 and at least 14 weeks’ gender-neutral parental leave.
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.


EMS/BMS Lead

Location: Bejing

Ready to push the limits of what’s possible?
Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

As an Automation Lead for EMS/BMS Systems within the Insulin Factory Beijing (IFB) project and part of our Global Manufacturing Systems & Automation team, you will be responsible for the planning, integration, and delivery of automation solutions for building and environmental monitoring systems. You will report to the Automation Project Lead and work at the interface of facility systems, GMP compliance, and digital manufacturing.

Main Responsibilities:

  • Lead the end-to-end automation scope for EMS and BMS systems within the IFB project, ensuring timely and compliant project execution in line with cost, schedule, and quality targets.
  • Define and manage system architecture and interfaces between EMS/BMS and related systems (HVAC, cleanroom/Storage monitoring, SCADA, PCS/DCS, Data Historian, Utility,  and MES).
  • Ensure EMS/BMS systems support GMP-critical monitoring (e.g., temperature, humidity, differential pressure, particle counts), facility control (e.g., AHU, lighting, access), and integration with alarm management.
  • Act as the primary point of contact for internal stakeholders (QA, CQV, CSV, Engineering, HSE, ITS) and external suppliers for EMS/BMS topics.
  • Support and supervise commissioning and qualification activities (e.g., AIV/ACO), including integration testing and functional verifications of GMP-critical systems.
  • Drive compliance with computerized systems validation (CSV) and data integrity (DI) standards as per GAMP5 and current regulatory expectations.
  • Provide and maintain comprehensive documentation such as User Requirement Specifications (URS), Functional Specifications (FS), and risk assessments.
  • Enable connectivity between EMS/BMS and digital platforms to facilitate advanced monitoring, predictive maintenance, and energy optimization.

About You:

  • Degree in Automation, Building Technology, or related engineering discipline
  • Experience in delivering EMS/BMS systems in GMP-regulated pharma or biotech projects
  • Strong technical knowledge of building automation (e.g., Siemens Desigo, Honeywell, Johnson Controls, Schneider Electric, or similar)
  • Familiar with GxP-compliant HVAC/cleanroom systems and critical environmental monitoring
  • Proficient in CSV, GAMP5, and data integrity frameworks
  • Excellent project coordination and stakeholder management skills
  • Fluent in English; knowledge of Chinese or other languages is a plus

Why choose us?

  • Innovative environment: Work with cutting-edge automation and digital transformation technologies.
  • Career growth: Develop skills in a dynamic and evolving field with ample opportunities for progression.
  • Impactful work: Play a crucial role in enhancing operational efficiency and digitalization in insulin production.
  • At Sanofi, we celebrate diversity and inclusion, ensuring equal opportunities for all. Join us as we pursue progress and discover extraordinary together!

Lead groundbreaking automation within the IFB project in a supportive and innovative team, shaping the path to manufacturing and supply excellence for insulin production at Sanofi. This role is critical to our team’s success and offers exposure to a broad range of activities. For an ambitious automation engineer, it’s a chance to gain a lot of experience quickly.

Anthony Le Marre, Global Head of Manufacturing systems & Automation

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. 

Design & Qualification Manager

Location: Bejing

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.

Main responsibilities 

The Quality D&Q Manager IFB (Design & Qualification, Insulin facility Beijing) ensures compliance with FDA, EMA, and Chinese Pharmacopoeia regulations for equipment design and qualification in IFF, Annex 15 and applicable regulations. The Quality D&Q Manager IFB co-develops Design and integrated C&Q strategy with the goal of compliance and state-of-the-art cGMP design and Qualification. Quality D&Q Manager IFB provides expert guidance on cGMP biologics Design and Qualification activities, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), DQ, IQ, OQ and PQ and complex equipment qualification. Provide expert oversight and review of documentation while identifying and mitigating risks. Monitor compliance and support design reviews and qualification of facilities, critical utilities, equipment, and computerized systems to ensure timely execution. 

As an integral part of the project quality team, this position has overall responsibility for participating in project workstreams, ensuring proper execution of design/qualification/validation strategies as well as providing support and guidance for quality processes and procedures. 

This role is expected to work independently and with a level of autonomy and authority in decision-making to ensure on-going compliance against approved documents and current Good Manufacturing Practices across the project during conceptional, basic and detailed design, construction C&Q, PQ, Validation and future site organizations until final approval. 

Management: 

  • Ensures the project is performed according to the Sanofi Standards and Good Practices. 
  • Ensures regular reporting to the Quality Design & Qualification Head IFB. 
  •  

Commissioning & Qualification and Validation: 

  • Responsible for the project C&Q&V strategy and execution, C&Q&V plans and System impact assessment.

  • Ensures IFF Quality Concepts development and Implementation during Design Review (DR), act as Quality review and support Process Engineering Team (URS, PID, technical documentation).

  • Responsible for the oversight of the preparation and the execution of DQ, SAT, FAT, IQ, OQ and nP-PQ protocols, final CQ reports and VMP

  • Interacts with the IFF to keep benchmark and best practices cross-fertilization.

  • Responsible for the consistency of the turnover package to system owners.

  • Responsible for Quality oversight of Supplier Qualification Engineering activities (e.g. FAT, SAT, Vendor documentation and test execution). 

Project Control, Cost & Schedule: 

  • Supporting the regular collection of actual quality C&Q project cost and progress.

  • Ensures the project compliance with Sanofi Cost & Schedule Policies and Standard.

About you

Experience 

  • 3-5 years industry experience, preferably within the biopharma and/or related regulated industry focus on Quality System Management. 
  • Knowledge & experience in Commissioning & Qualification, Process Validation Lifecycle, Quality by Design principles, transversal validations activities, as well as Pharmaceutical Manufacturing with production processing including automation, scientific writing, effective oral and written communication skills, and innovative thinking. Familiarity with strategic planning, balanced judgment and risk analysis. 
  • Experience working on large capex projects in Asia (China, Singapore, etc) is a strong asset. 
  •  

Soft skills 

  • Collaborate effectively with peers, stakeholders, partners across the organization to positively impact business results. 
  • Act for innovation, initiating new and improved ways of working. 
  • Develop teams in anticipation of future business needs. 
  • LEAN oriented, problem solving & new way of working. 
  • Open minded and curios to learn new tools. 

Technical skills 

  • In-depth knowledge of the biologic product license application process, and the associated regulatory requirements. 
  • Know-how in Quality systems, Quality Risk Management, Continuous improvement management, GxP and health regulated regulations, International and FDA exposure, KNEAT solution is a plus. 

Education 

  • Degree in Engineering/Science/Pharmacy or equivalent. 
  • Ideally MSc or PhD level qualification in Science. 

Languages 

  • Excellent communication skills (written and oral) in English 
  • Chinese (Mandarin) is a strong asset. 
Why choose us?
  • 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 and at least 14 weeks’ gender-neutral parental leave.
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.

 

Instrumentation and Controls Lead

Location: Bejing

Ready to push the limits of what’s possible? Join Insulink in one of our engineering functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. As an Instrumentation and Controls lead Engineer for the new Insulin Bejing facility’s project within our Global Manufacturing Systems & Automation team, you’ll be part of Insulin automation’s team and report into an Automation Project lead for China. You will execute instrumentation and control (I&C) activities supporting automation deliverables for Insulin Beijing strategic capital projects. This position is responsible to lead as the I&C subject matter expert and manage development, concept, design, commissioning, qualification and maintenance of instrumentation used for automated systems.

Main responsibilities:
  • Ensure project implementation aligns with customer orders in terms of costs, deadlines, quality, and resources; coordinate with the project team, operators, and supervisors, while initiating corrective actions for any deviations
  • Serve as the technical I&C subject matter expert for the Beijing Insulin facility, providing expertise in the concept, design, selection, commissioning, and qualification of instrumentation in both GMP and non-GMP environments, and offering guidance on automation implementation
  • Define automation requirements during the detailed design phase, supporting the preparation and review of I&C deliverables like Instrument Lists, IO Lists, wiring diagrams, fieldbus segment diagrams, riser diagrams, and control panel design drawings
  • Lead troubleshooting efforts and work with various trades during field walkdowns, installation, and commissioning activities to ensure instrumentation meets design specifications, and support the resolution of I&C issues during design, construction, and site installation
  • Review instrumentation specifications and participate in design reviews, providing technical guidance to I&C contractors and third-party vendors to ensure adherence to standards; lead as I&C representative in FAT, SAT, and Critical Test Plan execution
  • Oversee the quality of controls hardware and instrumentation installation during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) to ensure compliance with design requirements
  • Lead updates to I&C design documentation during all stages of Commissioning and Qualification (C&Q) and ensure alignment with the automation philosophy and strategy throughout project execution
 About you
  • Experience: Experience in applied instrumentation and controls and automation design engineering and project experience are required. Additional experience in construction/installation, equipment start-up, qualification and/or validation is mandatory; Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors and integrating various OEM automation software
  • Soft and technical skills: Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies; Strong leadership, technical writing, and communication/presentation skills
  • Education: Minimum B.Sc in Electrical, Automation Engineering or Computer Science or equivalent job certificate/education
  • Languages: Proficiency in English and Chinese is essential; German language skills are a plus
Why choose us?
  • Innovative environment: Work with cutting-edge automation and digital transformation technologies.
  • Career growth: Develop skills in a dynamic and evolving field with ample opportunities for progression.
  • Impactful work: Play a crucial role in enhancing operational efficiency and digitalization in insulin production.
  • At Sanofi, we celebrate diversity and inclusion, ensuring equal opportunities for all. Join us as we pursue progress and discover extraordinary together!
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Lead groundbreaking automation within the IFB project in a supportive and innovative team, shaping the path to manufacturing and supply excellence for insulin production at Sanofi. This role is critical to our team’s success and offers exposure to a broad range of activities. For an ambitious automation engineer, it’s a chance to gain a lot of experience quickly.

Anthony Le Marre, Global Head of Manufacturing systems & Automation

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.