We at Siemens Healthineers™ are committed to helping healthcare providers globally to succeed in today’s dynamic environment. We are inspired to transform the way things are done – because we want what is best for our people, our customers and ultimately the health of mankind. While we are invested in engineering excellence – leading-edge medical technologies and services, we don’t stop there. We’re also deeply invested in our 46.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in this industry. And as we strive to shape the future of healthcare, our overall success will depend on our ability to continuously reinvent ourselves.
If you are ambitious and change makes you thrive, help transform Siemens Healthineers into a learning organization.
In this role the individual will be responsible for participation on validation and qualification activities for process, equipment, facilities and utilities of an IVD manufacturing facility to be built in China. Will work closely with the other project core team leads/functions, e.g., Manufacturing, Technical Operations, Engineering and Quality Assurance, to ensure that equipment /processes are appropriately qualified/validated in a timely manner.
Specific responsibilities include but not limited to:
• Support in development of site Validation Master Plan and validation schedule.
• Create and develop individual qualification and validation protocol and report.
• Work with Engineering/ Manufacturing on specific equipment, facility and utility validation plans and reports.
• Ensure that all qualification/ validation plans, protocols and reports are complete, accurate and compliant with applicable requirements, including those of the China FDA and GB/ YY practice.
• Support to implement required periodical validation as VMP and revalidation for specified change.
• On site review and check for the qualification and validation execution, to make sure comply with the protocols.
• Support the risk management activities related to process.
• Support technical/manufacturing transfer activities.
This position may suit you best, if building learning organizations is your expertise and you have extensive experience with Top Management Learning and Leadership Development.
• A minimum of 3 years in the medical device, biotechnology or pharmaceutical industry, with a Quality Engineer or Validation Engineer role. • Able to read the English procedure and report.
A minimum of a 4 year degree is required.
Job ID: 88093
Organisation: Siemens Healthineers
Experience Level: Early Professional
Job Type: Full-time