Process Engineer - Cell Culture
takeda
Neuchâtel, Switzerland
vor 12 Std.

Process Engineer - Cell Culture

Job ID SR0052773 Date posted 09 / 02 / 2020 Location Neuchâtel, Switzerland

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do.

We live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives including your own.

JOB SUMMARY :

The scope of this role is to act as Cell Culture process engineer within the Manufacturing Sciences Department (MS) at the Neuchâtel facility ensuring process performances for a recombinant protein during USP activities.

The jobholder will lead projects related to process improvement and technology transfer from or to other Shire facilities.

The jobholder will support manufacturing and quality departments regarding impact assessment, investigation and troubleshooting.

Main activities :

  • Lead process improvement projects or activities
  • Develop and optimize process parameters
  • Ensure process performances through Quality by Design (QbD) and Continuous Process Verification (CPV) approaches
  • Identify business opportunities
  • Ensure communication and act proactively in case of performance trending
  • Lead and / or support investigations related to deviation / CAPA process
  • Perform product impact assessment for deviation
  • Lead projects or activities related to Cell Culture process or equipment (from User Requirements Specifications to Process Performance Qualification)
  • Support validation activities
  • Support or present topic during regulatory inspections
  • Support technology transfer
  • Education / experience and abilities

  • Minimum 3-5 years of experience cell culture area for recombinant protein.
  • Engineering or university degree in biotechnology
  • Language skills : Fluent in English and French
  • Knowledge of cGMP and quality requirements
  • Able to deal with statistics (six sigma certification is a plus)
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