Sr Manufacturing Engineer – Product Information

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

Main Tasks & Responsibilities:

1.      Product Information support

·        Complete the design and development of labels, IFU for Clinchem, Immunology, Tissue, Molecular diagnosis products etc., coordinate the timely availability of the content of label-related documents (such as labels, instructions for use, etc.), and be responsible for managing the documents in the system.

·        Documents to support the product information team for product registration.

·        Manage and coordinate UDI-related topics to meet compliance requirements.

·        Response for the printing production routine works in AIDA and SAP.

·        Create and manage SOPs and solutions documents to ensure GxP compliance.

2.      Printing Technical support:

·        Subject Matter Expert of Roche Printing related system, e.g. AIDA, AIDA PM, Reagent Registration，Coprosys/RILacsys, Elisys etc.

·        Responsible for production technical support based on Zebra printers and other customized printing equipment

·        Lead printing-related innovation and renovation projects.

·        Responsible for the printing equipment Qualification.

·        Responsible for the initiation and coordination of Change processes in the scope of Product responsibility.

3.      Cross-functions communication.

·        Coordinate the product information communication between the global product information operation team and the Suzhou site.

·        Provide cross-functional coordination and issue resolution including project-related responsibilities.

·        Coordinating the content management activities for In China for China products and In China for APAC products.

·        Participate in product transfer projects as product information team representative.

·        Support global printing technology import work.

4.      Project support and continuous improvement

·        Lead process optimization projects/trials to fulfil customer / commercial requirements and other business needs.

5.      Others

·        Other tasks assigned by the line manager.

Qualification & Experience:

A bachelor's degree in the following disciplines: 
 Natural sciences education background in manufacturing, engineering, bioengineering/pharmaceutical sciences, or equivalent. 
 Language Category

3+ years of experience in instruction manual/label design, production, management, or related roles.
3+ years of experience in packaging engineering or printing-related works.
Good at MS Office software as well as Adobe InDesign and basic validation skills

cGMP or IVD experience is preferred 
Experience in packaging engineering  development engineering is preferred 

SAP knowledge is preferred
Good at Adobe InDesign, Illustration skills

CET-6 or equivalent qualification  

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.