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Senior Manufacturing Systems Expert

2+ 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: Senior Manufacturing Systems Expert / Manufacturing Systems Expert (m/f/d)

Job Location: Schaftenau, Tyrol, Austria
Department: Manufacturing Execution Systems (MES)
Employment Type: Full-time
Language Requirement: Fluency in German and English


About Novartis

Novartis is a global pharmaceutical company dedicated to reimagining medicine to improve and extend lives. Our Schaftenau manufacturing plant is one of Austria’s most advanced drug production facilities, focusing on biological drug products. As a Senior Manufacturing Systems Expert, you will play a critical role in optimizing manufacturing execution systems (MES), enhancing operational efficiency, and ensuring the seamless production of life-saving treatments for patients worldwide.


Job Purpose

The Senior Manufacturing Systems Expert will be responsible for providing technical expertise and operational support for MES PAS-X software implementation, maintenance, and optimization. This role involves collaborating with automation engineers, process experts, and quality personnel to improve manufacturing processes while ensuring compliance with industry standards and regulatory requirements.


Key Responsibilities

Manufacturing Execution & System Implementation

  • Understand and translate drug product manufacturing processes into MES PAS-X.
  • Provide technical expertise for MES PAS-X software implementation, testing, and validation.
  • Author master batch records, configure system interfaces, and manage user access and audit trails.

System Optimization & Troubleshooting

  • Conduct root cause investigations for errors and bugs in MES PAS-X, implementing corrective actions.
  • Work closely with automation engineers and process experts to identify process improvements and propose MES PAS-X solutions.
  • Maintain and update Lifecycle Documents, Functional Specifications, and Test Documents.

Training & Compliance

  • Train production and quality personnel on MES PAS-X functionality and best practices.
  • Support health authority inspections, audits, and periodic validation reviews.
  • Ensure compliance with Good Manufacturing Practices (GMP), Computerized Systems Validation (CSV), and other regulatory requirements.

Required Skills & Qualifications

Essential Qualifications

  • Degree in IT, Engineering, Computer Science, or a related field.
  • Minimum 2 years of experience in a regulated industry (food, drug, or medical device manufacturing).
  • Strong knowledge of Manufacturing Execution Systems (MES) and their applications.
  • Ability to translate business requirements into automation solutions.
  • Fluency in German and English (both written and spoken).

Desirable Qualifications

  • Experience with PAS-X and SAP.
  • Practical knowledge of Computerized Systems Validation (CSV).
  • Familiarity with automation technologies and computer programming.

Key Skills Required

Automation Technology
Manufacturing Execution Systems (MES)
PAS-X Software Implementation & Optimization
Computer System Validation (CSV)
Troubleshooting & Root Cause Analysis
Teamwork & Collaboration
Regulatory Compliance & GMP Standards


Compensation & Benefits

  • Minimum Salary: €64,023.54 per year (based on collective bargaining agreement; actual salary will be significantly higher based on experience and qualifications).
  • Incentive Program & Competitive Salary aligned with industry standards.
  • Company Pension Scheme and Childcare Facilities.
  • Learning & Development Programs for career growth.
  • Worldwide Career Opportunities within Novartis.

Diversity, Inclusion & Accessibility

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

Reasonable Adjustments: If you require any accommodations during the recruitment process due to a medical condition, physical disability, or neurodivergent condition, please contact disabilities.austria@novartis.com.

Join Novartis and be a part of our mission to deliver life-saving treatments to patients worldwide!