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.