BioNTech SE

清洁和合规高级工程师

BioNTech SE  •  Nantong, CN (Onsite)  •  2 hours ago
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Job Description

About the Role

We are looking for a training and compliance professional to build and maintain the production department’s training and compliance systems at BioNTech (Nantong). You will design and deliver role-based training, track and assess its effectiveness, and ensure employees are qualified and authorized before performing their duties. You will also oversee shop-floor compliance, inspections, and internal and external audits, helping prevent human-error-related deviations and productivity losses.

Your Contribution

  • Establish and continuously improve the workshop’s GMP compliance and training systems.
  • Review workshop procedures and SOPs, and proactively identify, assess, monitor, and report GMP compliance risks.
  • Conduct shop-floor inspections and follow up to ensure identified findings are addressed and closed.
  • Organize GMP self-inspections and support external GMP inspections; analyze findings, coordinate resources, and lead corrective actions through completion.
  • Gather departmental training needs and develop and implement annual company training plans and role-based workshop training plans in line with business and workshop development goals.
  • Develop internal training resources, organize and oversee on-the-job training, and coordinate training assessments across roles.
  • Deliver onboarding and refresher training for new and existing employees, including training on relevant SOPs, SMPs, MBRs, and OJT requirements.
  • Design and develop systems for evaluating training effectiveness; analyze and summarize results and drive continuous improvement.
  • Undertake other duties as assigned by the manager.

A Good Match

  • Knowledge of GMP requirements and production-workshop compliance practices.
  • Experience or capability in developing training programs, delivering role-based training, and assessing training effectiveness.
  • Ability to conduct inspections, analyze audit findings, coordinate stakeholders, and drive corrective actions to completion.
  • Strong organizational, communication, and follow-up skills, with a continuous-improvement mindset.
BioNTech SE

About BioNTech SE

Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.

BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.

BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.

Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html

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Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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