Process Validation Expert - Biotech Drug Substance / no-685

Status: 
closed
Location: 
4070 Basel (Klybeck)
Start Date: 
2018-08-15
End Date: 
2018-12-31
Hours per day: 
8,00
Hours per week: 
40,00
Workload: 
100%
Total Hours: 
792
Assignment: 

Background

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

  • Type of placement:  5 months, external contract with possible long term extension
  • Company:  major Pharma company in Basel area

 

Duration: until end of year, but extension possible if candidate is a good fit. 

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

 

Job description

  • Author process validation and cleaning validation reports for biotech drug substance processes (upstream and downstream). 
  • Analyze and evaluate process data from executed validation studies. 
     
Requirements: 

Prerequisites: 

  • Thorough understanding of biotech (mammalian cell based) manufacturing processes and related process equipment (USP and DSP). 
  • Experience in process validation. 
  • Expertise in reviewing and writing technical reports in English 
  • Experience in biotech process validation or biotech cleaning validation (plan and report writing) 
  • Experience in regulatory affairs particular in writing module S25 is a plus 

IMPORTANT: we look for experts in biotech drug substance manufacturing process validation (NOT equipment qualification, not analytical method validation, not computer validation) 

Languages: English fluent (must), German (is a plus) 

Education (minimum): BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology.