M&S - IFB - Downstream Maintenance Lead
About this opportunity
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 downstream process systems (DSP) maintenance activities (e.g., chromatography, crystallization, drying) 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 DSP within IFB project ensuring later installation, commissioning, and operation of DSP 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 DSP
Participate in HAZID/HAZOP analysis with process risk team to help improve Design.
Drive the design, specification, and implementation of maintenance activities for DSP operations, ensuring compliance with GMP and Sanofi standards
Act as the primary interface for DSP 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 DSP, ensuring seamless data flow and operational performance across the manufacturing floor. This role ensures the stable, efficient, and compliant operation of DSP 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 DSP
Initiate and maintain technical communications with equipment suppliers, while systematically tracking all after-sales service activities
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
Soft and technical skills:
Good communication (internal and external), teamwork, problem-solving skills
Education:
bachelor’s degree in industrial engineering domain: Mechanical/Electric engineering/ Automation/ Mechatronics/Pharmaceutical engineering
Languages:
Chinese , Engineering English
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 !
Job details
How this role compares
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We currently track 1527 comparable Manufacturing & CMC roles across 125 biopharma companies.
Salary context
456 of 1527 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
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Seniority mix
705 of 1527 peers have a known seniority level
Therapeutic area mix
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