Master Batch Record Specialist

4 days ago


Millburn, New Jersey, United States Novartis Group Companies Full time

Job Description Summary

The Master Batch Record Specialist plays a pivotal role in supporting Manufacturing Execution Systems (MES) operating sites by providing expert design and business process support. This role is responsible for the delivery and updating of MES Design Elements, ensuring alignment with global core processes. It also includes the responsibility of providing basic MES trainings and best practice sharing across Novartis Radioligand Therapy sites, enforcing process standardization and harmonization, and managing future MES business requirements.

Key Responsibilities

  • Designing and updating Master Batch Records in alignment with global core processes.
  • Providing business support during Site MES Deployment Projects.
  • Conducting site Process Analysis and fit-gap analysis for project preparation in coordination with Global Process Business Owners.
  • Managing and updating guidelines based on global MES governance rules.
  • Reviewing and consolidating MES software errors, prioritizing fixes in collaboration with the MES IT team.
  • Attending Change Advisory Board meetings and prioritizing MES Business Change requests.
  • Ensuring effective collaboration across all business units and manufacturing facilities.
  • Maintaining the Global Process Model and conducting regular training sessions on MES.

Requirements

  • Bachelor's degree in business administration, economics, computer science, information technology, or related field.
  • Specialist: 3+ years or relevant experience in MBR design, preferably within the pharmaceutical industry.
  • Previous GMP experience is required.
  • Proven track record of collaborating across boundaries and influencing without authority.
  • Interaction with senior management and leveraging digital technology/big data.
  • Relationship management experience and multinational global exposure.
  • Ability to manage challenges and think proactively.
  • Willingness to undertake business travel and adapt to remote working conditions.
  • Good communication skills and readiness to learn new technologies.

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