Manufacturing Specialist

This role is located on-site in Indianapolis, IN. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Shift: Weekend Nights - position may involve mandatory overtime as needed

As a Manufacturing Specialist you will provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions.

Major accountabilities:

• Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
• Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.
• Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
  • Authoring/Owning investigations related to material