Senior Process Engineer-Filling

1 day ago


Tianjin, Tianjin, China Novo Nordisk Full time
About the Role

Novo Nordisk is seeking a highly skilled Senior Process Engineer to join our team in aseptic production. As a key member of our process engineering team, you will be responsible for ensuring production quality and compliance, preparing for audits, and driving process improvement initiatives.

Key Responsibilities
  1. Maintain compliance between authority requirements and Novo Nordisk standards, as well as global standards and local SOPs.
  2. Prepare for audits to obtain high ratings in internal audits and pass external inspections. Represent the Site Tianjin team during audits and inspections, and own internal or external audit findings.
  3. Be the CAPA owner for investigations, handle critical NCs/ICs/CCs quickly and efficiently, and ensure no comments during audits.
  4. Write critical CRs and complete changes on time.
  5. Own process risk assessments, plan and execute validations and re-validations with minimal production downtime, and write high-quality validation documentation.
Requirements
  • Minimum 7 years of relevant working experience, with at least 5 years in production experience in aseptic processes within the cGMP regulated pharmaceutical industry or life science industry.
  • Knowledge and experience in cGMP or GMP manufacturing process validation/qualification.
  • Experience working in cross-functional teams and strong documentation skills.
What We Offer

As a Senior Process Engineer at Novo Nordisk, you will have the opportunity to work in a dynamic and collaborative environment, driving process improvement initiatives and ensuring production quality and compliance. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.



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