40 days ago on simplyvision.ch

Validation Expert

SimplyVision GmbH

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Validation Expert

Status: 
active
Location: 
4070 Basel
Start Date: 
2018-01-01
End Date: 
2018-09-30
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
1.560
Assignment: 
Background

For our Swiss customer located in Basel we are currently looking for (m/f) a Validation Expert

• Type of placement: 9 months, external contract with possible long term extension

• Company: major Pharma company in Basel area

 

Job description
  • Author process validation reports for biotech drug substance processes (Upstream and Downstream). 
  • Analyze and evaluate process data from executed validation studies. 

 

Responsibility

The validation expert for biotech products is responsible to write process validation reports which will serve as source documents for a BLA (Biologics License Application). 

 

Requirements: 
  • Thorough understanding of biotech manufacturing processes and related process equipment (USP and DSP).
  • Experience in process validation.
  • Expertise in writing technical reports in englisch
  • Experience in regulatory affairs particular in writing module S25 is a plus
  • Languages: English fluent (must), German advantageous
  • Education (minimum): BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.