Automation in GMP Environments

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Questions and Answers

I have significant experience working with automated systems in ______-regulated environments.

GMP

While at Novartis, I worked extensively with ______ systems to monitor and manipulate critical process parameters.

SCADA

I adjusted temperature, flow rates, and other parameters to ensure optimal cell ______ and consistent product yield.

viability

I collaborated with Novartis’ automation engineers to develop process ______ for TFF1 systems and bioreactors.

<p>recipes</p> Signup and view all the answers

My role was to provide insights into the biological process ______, such as optimizing nutrient delivery.

<p>requirements</p> Signup and view all the answers

The principles of process automation are highly transferable to the ______ automation FCDI specializes in.

<p>assay</p> Signup and view all the answers

At DSM, I designed and implemented process recipes for ______ used in testing material properties.

<p>viscometers</p> Signup and view all the answers

This involved programming the equipment to perform specific tests under varying conditions, such as temperature and ______ rates.

<p>shear</p> Signup and view all the answers

This required a strong understanding of both the equipment’s capabilities and the material properties being ____.

<p>tested</p> Signup and view all the answers

I’ve gained a strong understanding of how to leverage automated systems to enhance throughput, accuracy, and ____.

<p>reproducibility</p> Signup and view all the answers

I’ve collaborated extensively with automation engineers to optimize workflows in ____-regulated environments.

<p>GMP</p> Signup and view all the answers

The principles of precise parameter control and workflow ____ are directly applicable.

<p>optimization</p> Signup and view all the answers

In my role at Novartis, I was responsible for monitoring and adjusting bioreactor parameters using ____ systems.

<p>SCADA</p> Signup and view all the answers

While I haven’t yet worked directly with liquid handling systems, my experience developing recipes for TFF systems and ____ has given me a solid understanding.

<p>bioreactors</p> Signup and view all the answers

Emphasize your familiarity with SCADA systems and process recipe ____.

<p>development</p> Signup and view all the answers

I’m confident in my ability to quickly learn and apply platforms like ____ Fluent.

<p>Tecan</p> Signup and view all the answers

Flashcards

SCADA Systems

Supervisory Control and Data Acquisition systems that monitor and control industrial processes, like bioreactors and TFF systems.

Process Parameters

Measurable factors influencing a process, such as temperature, flow rate, and pressure.

Process Recipe

A predefined series of steps and parameters used to control a manufacturing or testing process.

Automation Engineers

Engineers specializing in designing, implementing, and maintaining automated systems and processes.

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Cell Viability

The measure of how well cells are functioning and surviving.

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Product Yield

The amount of desired product produced relative to the input.

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Upstream Manufacturing

The early stages of manufacturing a biological process, like cell culture.

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Assay Automation

Automatic systems for performing laboratory assays and experiments in an automated fashion.

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Liquid Handlers

Automated equipment used for precise handling and dispensing of liquids in laboratory settings.

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Consistent Sample Preparation

Ensuring uniformity and repeatability in preparing and processing samples for lab tests.

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Viscometers

Instruments used to measure the viscosity of materials.

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Equipment Capabilities

Understanding the features and limitations of scientific equipment.

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Material Properties

Characteristics of the substance being tested.

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Workflow Optimization

Improving the efficiency and precision of procedures.

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Automation in Bioprocessing

Utilizing automated systems in biological processes.

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Automation for Material Testing

Automating procedures for evaluating material properties.

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Throughput Enhancement

Increasing the rate of work or production using automation.

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Accuracy & Reproducibility

Maintaining precision and consistency in results with automation.

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Manual Error Minimization

Reducing mistakes or errors in work by relying on automation.

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SCADA Systems

Supervisory Control and Data Acquisition systems for monitoring and controlling process parameters.

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Process Recipe Development

Creating step-by-step instructions for a specific process.

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Liquid Handling Systems

Systems for precise and automated manipulation of liquids, like Tecan Fluent.

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GMP-regulated environments

Environments that adhere to Good Manufacturing Practices regulations.

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Workflow Optimization in GMP-regulated environments

Improving the efficiency and precision of processes in GMP-regulated environments.

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Adaptability to automation platforms

The ability to quickly grasp and utilize new automation systems

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Translating Biological Processes to Automated Workflows

Converting biological procedures like cell growth into automated steps.

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Study Notes

Automation and Programming Experience Summary

  • Significant GMP experience: Extensive work with automated systems in Good Manufacturing Practice (GMP)-regulated environments.
  • Process control expertise: Developed and optimized process control recipes, supporting equipment functionality (e.g., bioreactors, TFF1 systems).
  • SCADA system proficiency: Monitored and manipulated critical process parameters using SCADA systems, adjusting temperature, flow rates, etc., to optimize cell viability and product yield.
  • Collaboration with engineers: Worked closely with automation engineers to develop process recipes, translating biological process requirements into operational workflows.
  • Process optimization: Improved system performance and product consistency through recipe development and parameter optimization.
  • Transferable skills: Experience in recipe development, parameter optimization, and process control directly applicable to assay automation, like programming liquid handlers and ensuring precise sample preparation.
  • Viscometer programming: Designed and implemented process recipes for viscometers, requiring programming for testing materials under varying conditions (temperature, shear rates).
  • Broad automation understanding: Extensive experience using automation across multiple roles (bioprocessing and materials testing), learning to leverage automated systems for enhanced throughput, accuracy, and reproducibility.
  • Adaptable to liquid handling systems: Confident in adapting to liquid handling systems (e.g., Tecan Fluent), given experience in precise parameter control and workflow optimization in GMP settings.
  • Quick learning: Frames themselves as a quick learner of new automation platforms, given strong process control and programming foundation.
  • Collaboration focus: Emphasize extensive collaboration with automation engineers to optimize workflows, contributing to recipe development.

Key Talking Points for Interview

  • SCADA expertise: Highlight familiarity with SCADA systems and process recipe development, demonstrating understanding of programming logic and parameter control applicable to assay automation.
  • Transferable skills: Emphasize how experiences in bioprocess automation and material testing are directly applicable to assay automation.
  • Quick learner: Frame lack of direct liquid handler experience as an area of quick learning given strong process control foundation.
  • Collaborative approach: Showcase collaborative nature and ability to work effectively with automation engineers.

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