Info
Schaftenau
Schaftenau, Austria
Novartis
Novartis
Regular Full Time
Regular Full Time
Analytical chemist, Quality Control (QC), Laboratory instruments
Analytical chemist, Quality Control (QC), Laboratory instruments
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Expert Qualification and Automation AO (m/f/d)

Inactive
Novartis - Career

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

The Technology and User Services (TUS) group in NX is driven to help users use tools effectively to improve productivity and foster innovation. We deliver the Technology and User Services (TUS) group in NX to help customers use tools effectively to improve productivity and foster innovation. Our organization is here providing the technology backbone and devices that enable users to work in an office, lab or mobile environment.

Expert Qualification and Automation AO (m/f/d)

This role plans and performs equipment qualification and maintenance in a GMP-regulated environment, working closely with cross-functional teams and external partners. As system owner and instrument lead, the position manages qualification activities for complex lab systems and software. Responsibilities include overseeing Quality Plan projects, ensuring GxP compliance, supporting digitalization and automation initiatives (such as script programming and robotic system management), maintaining GMP-qualified status, managing changes and deviations, approving documents, and ensuring audit readiness for AO AT infrastructure. The role also promotes workflow standardization across sites and leads to the development and implementation of new digital processes and standards, focusing on robotics and end-to-end operation integration.

Key Responsibilities:

  • Plans, organizes, performs, and documents qualification and maintenance activities for equipment, facilities, and other laboratory or plant devices with minimal supervision. Acts as Instrument Responsible Person (IRP) and/or System Owner for analytical and storage equipment. Serves as SME for qualification, including compliance and third‑party management. Acts as expert for automation, supporting automated systems and digital solutions.
  • Ensures GMP compliance in all activities and maintains required regulatory documentation. Supports health authority inspections, identifies quality issues, and contributes to root‑cause analysis and CAPA. Oversees quality aspects of projects involving instruments, quality plans, training, IT validation, and external partners. Drives improvements in quality performance, compliance, risk management, reporting, and digital/automated systems.
  • Understands and applies practices, concepts, and processes within the relevant scientific or technical discipline. Contributes to the development or optimization of methods, procedures, and work instructions. Participate in evaluation and implementation of new laboratory equipment, supporting process, quality, and compliance improvements (including automation and digitalization).
  • Writes protocols, reports, and laboratory procedures based on templates under moderate supervision. Operates within clearly defined procedures, with some decision‑making latitude for expected issues. Works according to standards for quality, ethics, health, safety, environment, and information security.
  • Recognizes, communicates, and contributes to solving complex problems such as deviations or unexpected experimental results. Addresses and resolves issues within own area of responsibility, with adherence to established guidelines.
  • Actively participates in knowledge exchange across teams. Trains and coaches’ technicians and employees in training programs or onboarding.

Essential Requirements:

  • Technician with analytical/laboratory relevant experience or degree in a scientific discipline (e.g. Pharmacy, Chemistry, Biotechnology etc.).
  • Good scientific or technical knowledge in a pharmaceutical area.
  • Good knowledge/skills of laboratory and/or technical tools.
  • Good knowledge of software and computer tools, programming/coding experience is beneficial.
  • Awareness for safe handling of chemicals, potentially dangerous materials, and equipment.
  • Project management and negotiation skills.
  • Fluent in English, German is an advantage.
 

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