Job Information
Job title: Associate Engineer, Inoculation
• Location: Shenzhen, Guandong Province, China
• % Remote working and % of travel expected: N/A
• Job type: Full time
• Site/Unit: Beijing Site/ M&S China
About the job
Our Team:
The M&S division encompasses manufacturing platforms built on 3 global business units, along with supporting functions including Quality, Supply, and Lean Strategy. It is dedicated to manufacturing high-quality medicines and delivering them to patients through outstanding strategies and tools.
• Ensure all distribution and marketing activities of products operated by Sanofi entities in China are in compliance with Sanofi Quality Policy, Quality Standards and applicable regulatory requirements.
• Manage quality processes and perform quality control activities as defined in procedures, especially those established in accordance with current GSP/GDP regulations.
• Provide strong quality support to innovation and business initiatives, including digital transformation projects.
• Promote a quality culture and quality mindset across the organization, ensuring compliance with both global Sanofi standards and local Chinese regulatory requirements.
Main responsibilities
1. Team management and Personal development
• Pay attention to health,safety and production environment requirements, and improve and adjust accordingly if necessary
• Responsible for the inoculation steps in the production of influenza stock solution, and complete all related operations of virus inoculation preparation, inoculation and cultivation. Then the inoculated chicken embryos and eggs are cultured to multiply the virus and delivered to the harvesting group; daily cleaning and disinfection, material preparation and environmental monitoring are carried out. Comply with quality and health, safety and environment regulations in production operations, ensure safe and effective production operations, and provide technical support to the team and other departments.
2. Work Delivery
• Ensure staff training and qualification according to the requirements; Ensure the supply of material and manpower deployment;
• Participate in the production operation of the inoculation process, ensure safe, compliant, and effective production operations, and deliver products on time, quality and quantity;
• Ensure production activities according to related procedure, standard operating procedures and batch records, supervision and inspection records of area.
• Ensure data integrity in production activities meets requirements;
• Participate in the writing and execution of all validation plans/reports in this group.
• Provide/enter relevant production data (MES, SAP, CMS, One LIMS,SMS2.0, SPCetc.) on time;
• Timely report and assist in resolving issues that arise during production; Responsible for writing relevant technical documents; Participate in investigating deviations that occur in the production field; Timely completion of CAPA;
• Responsible for receiving production materials and solution containers in the vaccination area, ensuring the supply of production materials, following up on non BOM material inventory, and timely applying for procurement.
• Lead and train new employees, and ensure that new employees are qualified for on-the-job operation.
3. Quality system implementation
• Handling and investigating deviations in the production field; Propose evaluation and change control based on the actual situation, and timely complete the CAPA.
• With the assistance of relevant departments and continuous improvement teams, complete the required calibration/validation/validation activities for the machine/equipment/plant on time.
• Actively participate in workshop GMP self inspection to promote departmental GMP compliance. Supervise and urge the workshop to continuously improve.
• Undertake the relevant authorization responsibilities of the inoculation supervisor of the bulk production department, and review and sign GMP related documents.
• Deliver specified continuous improvement projects or other work objectives.
4. Goal realization, the implementation of company values and culture
• Achieve departmental goals, conduct regular reviews to achieve the company's development direction.
• Strengthen communication and cohesion within the department and across departments, to ensure the achievement of work objectives and maximum efficiency.
• Take the Lead Value: Aim Higher; Act for Patients; Be Bold; Lead Together.
• Obey the work arrangement of the department or the direct superior, and actively participate in the backup and transfer of different positions.
About you
Experience:
• Work experience: 3+ years of relevant experience in the pharmaceutical industry.
Soft skill:
• General skills: Proficient in office software such as Word, Excel, and PowerPoint. Demonstrates team leadership, cross-functional collaboration, and good communication skills.
Technical skill:
• Professional skills: Familiar with pharmaceutical regulations such as GMP and the Pharmacopoeia. Skilled in writing documents, procedures, and guidelines, and able to apply risk analysis methods.
Education:
• Education background: Full-time college diploma or above; familiar with biochemistry, microbiology, virology, and physical chemistry.
Language requirement: Good proficiency in both Chinese and English languages
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, disability, or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
Take The Lead Behaviours: Aim Higher, Act for Patients, Be Bold and Lead Together
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!