IFB - Upstream Maintenance Lead

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

Please indicate here the main job responsibilities

During Project stage

·       Collaborate strongly with IFF Program teams to Manage all insulin upstream process systems (USP) maintenance activities (e.g., cell culture, fermentation, separation, disruption, isolation, washing, folding and enzymatic cleavage) from Basic Engineering to Detailed Design studies with optimized solutions leveraging Frankfurt process replication while integrating China local rules & codes.

·Collaborate to URS, maintainability reviews (P&IDs, Layout, 3D model, Flows…), FMECA sessions for USP within IFB project and URS/ Tech Spec reviews ensuring later installation, commissioning, and operation of USP equipment in line with reliability, accessibility, detachability, detectability, operability of energy control device, integrity of protective device, availability of hazardous substances control, and resource expectations.

·       Participate in and provide technical support for FAT, commissioning, SAT, qualification activities and start-up on USP.

·Participate in HAZID/HAZOP analysis with process risk team to help improve design.

·Drive the design, specification, and implementation of maintenance activities for USP operations, ensuring compliance with GMP and Sanofi standards.

·Act as the primary interface for USP with internal work teams such as Process, Automation, CQV, CSV, and Digital, as well as with external vendors and engineering partners.

During operation stage

·Oversee the daily maintenance, preventive maintenance (PM), troubleshooting, and emergency repair of equipment in insulin USP, ensuring seamless data flow and operational performance across the manufacturing floor. This role ensures the stable, efficient, and compliant operation of USP to meet production schedules, quality standards (GMP), and regulatory requirements (FDA/EMA).

·Involved in Greenfield Integration, including specific equipment related with CUB/ Warehouse/ WWTP.

·Strictly comply with maintenance/calibration SOPs and EHS regulations, be proficient in LOTO and other safety procedures.

·Develop and maintain clear documentation, functional specifications, and testing protocols for USP.

·Initiate and maintain technical communications with equipment suppliers, while systematically tracking all after-sales service activities. Suppliers' selection for packages and local maintenance service Local contracting strategy

·Oversee spare parts inventory status, maintaining precise stock records and initiating procurement based on annual maintenance plans and equipment failure analysis to minimize MTTR.

·Work in close coordination with multiple departments including EHS, PD, QA, QC and others to achieve operational excellence.

·Regularly engaged in technical problem-solving discussions in English with IFF maintenance teams.

About you

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

• More than 10 years of PD equipment maintenance experience in the pharmaceutical industry (preferred), or in GMP-regulated industries such as biotechnology/fine chemicals/food and beverage.

• Familiarity with mechanical structure, working principles of PD equipment and experience in maintain.

• Familiarity with GMP standards/compliance, including data integrity requirements, change control, deviation handling, preventive maintenance, and calibration.

• Proficiency in writing and reviewing GMP documents such as maintenance work orders, preventive maintenance plans, spare parts inventory management, deviation reports, and change control.

• Proficient in common office software and maintenance software.

• Good communication (internal and external), teamwork, problem-solving skills

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• Education: bachelor’s degree in industrial engineering domain: Mechanical/Electric engineering/ Automation/ Mechatronics/Pharmaceutical engineering

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• Languages: Chinese (Mandarin), fluent in engineering English

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