13 days ago on jobs.kellyservices.ch

Process Validation Expert - Biotech

Kelly Services (Schweiz) AG

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Process Validation Expert - Biotech

Kelly Scientific Resources (KSR), a division of Kelly Services, is the worldwide leading provider of scientific personnel. Our team in Basel (Switzerland) consists of experts with a solid background in chemistry, pharmacy or biotechnology, as well as several years of consultancy experience.

For our customer, an internationally leading pharmaceutical company with headquarters in Basel (Switzerland), we are looking for an experienced
 
Process Validation Expert – Biotech

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). 

Key Responsibilities and Tasks: 

  • Author process validation reports for biotech drug substance processes (Upstream and Downstream). 
  • Analyze and evaluate process data from executed validation studies. 
Requirements:  
  • BSc. in Chemistry, Pharmacy, (Bio-)Chemical Engineering or Pharmaceutical Technology
  • Thorough understanding of biotech manufacturing processes and related process equipment (USP and DSP).
  • Experience in process validation. 
  • Expertise in writing technical reports in English 
  • Experience in regulatory affairs particular in writing module S25 is a plus 
  • English is a must (German advantageous)
 
Contract duration: 10 month
Starting date: January 2018
Workplace: Basel


If you are interested in this career opportunity t hen please do not hesitate to apply directly online on www.kellyservices.ch or to send your complete application documents to us, preferably this very day!

Contact: Diana Steinhauer: diana.steinhauer(at)kellyservices.ch
We are looking forward to getting to know you!