清洁和合规高级工程师

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.