Sr Manufacturing Engineer Product Information

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

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