Job title职位名称: CSV Engineer CSV工程师

• Location工作地点: Beijing北京

About the job工作职责

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. Your job, as CSV Engineer within our M&S China-BEI Site, will be to making best class medicines with excellent strategies and tools and delivering them to our patients.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main responsibilities职责描述:

Please indicate here the main job responsibilities请列举该职位的主要工作职责。

• Develop & implement CSV strategy for OT systems
• Ensure compliance with GMP, GAMP, 21CFR11 regulations
• Manage CSV lifecycle for all OT systems
• Lead CSV activities, including risk assessments
• Implement data integrity measures for OT systems
• Drive continuous improvement in CSV processes
• HSE Responsibility

• Supervision and maintenance according to HSE related requirements, to ensure that engineering maintenance comply with HSE rules and relevant regulations.
• To maintain regular maintenance and ensure regular operation of safety equipment. Records of maintenance shall be made and signed by the persons concerned.
• Actively participate in HSE renovation and provide technical support.
• Organize and supervise the implementation of HSE rules and regulations.
• To supervise the Contractor's work and ensure that all work is in line with safety requirements.
• According to the relevant regulations of the state, the special operators have been trained in special safety operations and obtained the certificate for special operations.
• To participate in the +QDCI meeting every day to supervise the effective implementation.
• Actively participate in HSE risk assessment.
• For HSE issues, report promptly and organize timely rescue.
• Participate in the investigation of HSE incidents.
• Correct use of qualified and necessary personal protective equipment.
• Occupational health qualifications: Occupational disease protection equipment and occupational disease protection articles for personal use should be regularly maintained and overhauled, their performance and effect should be regularly tested to ensure that they are in a normal state and may not be dismantled or stopped using without authorization. Learn and master the relevant occupational health knowledge, abide by the laws, regulations, rules and operating rules of occupational disease prevention and control, correctly use and maintain occupational disease protection equipment and occupational disease protection articles for personal use.

About you 任职资格:

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

请列出胜任该职位所必须具备的条件。

• Expertise in CSV for Biopharma OT systems
• In-depth knowledge of GMP, GAMP, 21CFR11
• Project management skills for validation initiatives
• Risk management and assessment proficiency
• Data integrity and audit trail expertise
• Experience with validation tool implementation

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.

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