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Sterile Production Specialist

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Sanofi-Aventis Deutschland GmbH

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Location:
China , Beijing

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

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.

Job Responsibility:

  • Assist dept. manager to coordination of Project, plan, Quality and engineering to organise production with right volume, right quality, right cost and on right time
  • Supervise production, human resources, facilities to ensure all activities comply with China GMP and Sanofi regulations
  • Keep continuously improvement in terms of safety, quality, cost, delivery, motivation and environment
  • Continuously improve the compliance level of sterile production, attend and promote SMS execution, Lean manufacturing
  • Organize, coordinate, track and implement of deviations, changes, validation, complaints and global standards gap analysis etc
  • To ensure the continuous process compliance improvement through the management of quality systems
  • To ensure the implement of quality policy/objectives of Sanofi and to ensure the quality compliance of sterile production operation
  • To ensure effectiveness of sterile production quality improvement programs/projects
  • Perform the job duties of the Inspection Process-Centric Unit
  • Responsible for the shift work of PCU production (morning, middle and night)
  • Participate in process optimization, equipment improvement and technique innovation to sustainably improve OEE and yield, participate in SMS standards deep execution and continuously improve in 5S/HSE aspects and waste minimization
  • Optimize the production process, improve the equipment and system, consistently supply high quality production for commercial operation preparation
  • Sustainably improve yield of compounding, filling and inspection equipment and ensure the stable supply to the market
  • Management of the production environment, process, hygiene, facilities to make sure all production activities comply with drug master file, SOPs and GMP requirements
  • To review the batch production records and submit to Quality in time
  • To implement the equipment qualification, process validation according to the master plan
  • To execute and follow the required initial and continuous trainings of production operators
  • Organize daily production meeting, coordinate all shifts and keep closely communication with planning, QA, maintenance and warehouse etc., to implement production plan strictly and ensure right Plant Service Level and Bias
  • Follow up the actions of Change Control, CAPA for deviations or complaints related to production
  • Develop necessary SOPs and ensure the implementation and improvement
  • Implement SMS standards and continuously improve in 5S/HSE aspects and waste minimization
  • Report product complaints and adverse drug reactions according SOP requirements
  • Other tasks temporarily assigned by department manager
  • Sterile production Department HSE Responsibilities

Requirements:

  • At least a bachelor or above degree in pharmacy or biology disciplines with 0~2 years’ experience in quality or sterile area
  • Must be a committed 'Quality or Sterile' professional with knowledge of quality systems within the pharmaceutical or related industry
  • Thorough understanding of manufacturing processes and aseptic processes
  • Strong working knowledge of quality systems, regulatory requirements across multiple health authorities
  • Fluent English both in written and verbal
  • Good communication skills
  • Able to burden pressure
  • Brave to make decision
What we offer:
  • wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs
  • at least 14 weeks’ gender-neutral parental leave

Additional Information:

Job Posted:
January 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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Sanofi-Aventis Deutschland GmbH - All Job Offers
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