Process Validation Expert - Biotech Drug Substance

Harvey Nash is looking for a PROCESS VALIDATION EXPERT - BIOTECH for a 5 MONTH project in BASEL.

Duration: 15/08/2018 TO 31/12/2018

Location: BASEL

Workload: 100%

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

YOU ARE RESPONSIBLE FOR:

- Authoring process validation reports for biotech drug substance processes (Upstream and Downstream)
- Analysing and evaluating process data from executed validation studies
- Thorough understanding of biotech manufacturing processes and related process equipment (USP and DSP).
- Experience in process validation.

REQUIREMENTS:

- Expert in biotech drug substance manufacturing process
- Expertise in 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

LANGUAGES:

- English fluent (must),
- German advantageous

EDUCATION (MINIMUM):

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

Are you available immediately, have experience working within a Life Science company?

Please send your complete CV to(SEE BELOW)

For further details feel free to call me.

I am looking forward to receiving your application.