Jens Bruun

Subject matter expert - Automation and IT

"Developing an effective IT strategy, and executing automation and IT projects to achieve optimal utilisation of equipment, requires both IT know-how and a profound understanding of pharma and biotech manufacturing."

Jens Bruun has more than 30 years of experience within automation and IT, working with strategy, analysis, specification, design, development, implementation/validation and operational control of a variety of technologies.

Jens has extensive project management and consultancy experience in automation and IT that include the full life-cycle of the projects. He is a proven automation and manufacturing IT enterprise architect, with a TOGAF®9.1 certification as well the IT Governance certification COBIT®5. He holds a Master’s degree in engineering from the Technical University of Denmark.

Automation and IT systems are essential to make sure modern pharmaceutical products are produced efficiently and correctly the first time around.

Jens Bruun

What's your view on the industry?

"Automation and IT is an integrated part of modern manufacturing facilities. Developing an effective and consistent IT strategy – and executing automation and IT projects to achieve optimal utilisation of equipment – requires both IT know-how and a profound understanding of pharma and biotech manufacturing.

Automation and IT systems are essential to make sure modern pharmaceutical products are produced efficiently and correctly the first time around. It provides an overview of production data, which is critical for continuous improvement of production and business processes.

Choosing and designing the optimal IT solutions for a manufacturing plant or site considering the complex needs of the pharma industry is not an easy task. It requires in-depth knowledge of the multitude of systems and solutions available, as well as system integration and the interfaces to design for e.g. Process control systems, MES systems and Enterprise systems.

There are a range of regulatory requirements for documentation and qualification that systems have to comply with in pharma and biotech. This is essential both when developing the solution and in on-going operations."

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Expert in:

  • ISA-88, ISA-95, ISA-99, GAMP5, ITIL, COBIT and TOGAF
  • Manufacturing Execution Systems (MES)
  • Material and Inventory Control Systems
  • IT Compliance and Data Integrity
  • QBD and Risk based control strategies
  • Enterprise Manufacturing Intelligence (EMI)
  • Life Cycle Management
  • Enterprise Resource Planning Systems (ERP)
  • Electronic Batch Reporting (EBR) and review by exception
  • Validation Industry 4.0

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