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Specialist Mbr Designer

5+ years
Not Disclosed
10 Jan. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Specialist MBR Designer

Job Locations: Ljubljana, Barcelona Gran Vía, Hyderabad (Office), Prague
Department: DDIT ITOT Global Manufacturing
Employment Type: Full-time
Language Requirement: Fluent English (German and Slovenian are a plus)


About Novartis

Novartis is a leading global pharmaceutical company focused on innovation, technology, and process excellence. Our DDIT ITOT Global Manufacturing team is dedicated to implementing and optimizing Manufacturing Execution Systems (MES) to enhance manufacturing efficiency and regulatory compliance.

As a Specialist Master Batch Record (MBR) Designer, you will play a crucial role in the design, development, and standardization of MBRs across Novartis sites, ensuring the smooth deployment and operation of MES systems.


Job Purpose

The Specialist MBR Designer will be responsible for designing, implementing, and maintaining Master Batch Records (MBRs) in alignment with global Manufacturing Execution Systems (MES) standards. This role involves collaborating with global and local teams to support MES projects, enforce standardization, and improve operational efficiency across Novartis sites.


Key Responsibilities

MBR Design & Implementation

  • Design and update Master Batch Records (MBRs) in alignment with global core processes.
  • Provide MBR design support to MES implementation projects and operational sites.
  • Ensure process standardization and harmonization across all Novartis sites.

MES Project Support & Optimization

  • Provide business process and configuration support for MES implementations.
  • Collaborate with global and local teams for fit-gap analysis during MES project preparation.
  • Support updates to Standard Operating Procedures (SOPs) and global guidelines.

Training & Best Practices

  • Conduct MES training and facilitate best practice sharing across Novartis sites.
  • Actively participate in MES communities of practice to drive innovation and improvements.

Required Skills & Qualifications

Essential Qualifications

  • Bachelor’s degree in Pharmaceuticals, Chemistry, or a related technical field.
  • Fluency in English (German and Slovenian are a plus).
  • Experience in MBR design within MES systems (PAS-X or Opstrakker).
  • Knowledge of pharmaceutical manufacturing processes and regulatory requirements.
  • Strong analytical thinking and problem-solving skills.
  • Excellent collaboration and interpersonal skills for cross-site coordination.

Key Skills Required

MBR Design & MES Configuration
Manufacturing Execution Systems (MES) - PAS-X / Opstrakker
Process Standardization & Compliance
Analytical Thinking & Problem-Solving
Communication & Collaboration
Requirements Analysis & Gathering


Why Join Novartis?

At Novartis, you will have the opportunity to:
✅ Work with cutting-edge technologies in a highly skilled team.
✅ Contribute to global pharmaceutical manufacturing efficiency.
✅ Gain extensive MES experience through multi-site collaboration.
✅ Access career growth opportunities in a dynamic and innovative environment.


Diversity & Inclusion

Novartis is committed to fostering a diverse and inclusive workplace. We encourage applications from all individuals, regardless of gender, age, race, religion, sexual orientation, or disability.

Join us in shaping the future of pharmaceutical manufacturing with innovative MES solutions!