Chemical or Biotechnological Support (m/f)

Job type:
on-site
Start:
asap
Duration:
12 MM
From:
Hays AG
Place:
in North Rhine-Westphalia
Date:
07/05/2012
Country:
flag_no United Kingdom
project ID:
387749

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This project is archived and not active any more.
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We are looking for a
Chemical or Biotechnological Support (m/f)

Referenz: 186313/2-en
Beginn: asap
Dauer: 12 MM
Ort: in North Rhine-Westphalia
Branche: Sonstige Forschung und Entwicklung im Bereich Natur-, Ingenieur-, Agrarwissenschaften und Medizin

Ihre Aufgaben:
  • Maintaining operational readiness of pilot manufacturing process
  • Maintaining and extending process knowledge base
  • Trouble-shooting and streamlining of process by designing scale-up and scale-down experiments
  • Participate in project groups with manufacturing, QC & QA
  • Translate operational requirements into project plans, taking into account regulatory requirements
  • Conduct transfer of process modifications according to the project plan
  • Designing and directing pilot process
  • Write operating procedures and batch protocol for pilot process according to cGMP
  • Verify comparability between pilot and commercial process
  • Cross-training in clean room and process procedures
  • Preparation of pilot process batch record
  • Analyzing and documenting pilot process performance
  • Verifying comparability between pilot and commercial process


Ihre Qualifikation
  • Must Have:
  • Degree in Chemical or Biotechnological Engineering (Dipl-Ing, M. Eng. or equivalent)
  • Work experience (NLT 5 yrs) in fermentation or cell culture in a cGMP environment
  • Work experience (NLT 5 yrs) in API and/or DP production in a cGMP environment
  • Experience in biopharmaceutical equipment qualification and process validation
  • Fluent in German and English with excellent communication and written skills
  • Bonus:
  • Experience in process scale-up and scale-down from lab or pilot to production scale
  • Experience with process improvement tools, e.g. FMEA and six sigma
  • Experience with GEP



Skills:
- QM manager