Validation Engineers/Specialists

Process Validation Engineer / Specialist: collect, summarize and analyze submission batch, scale-up/down and process validation data including In-Process Manufacturing testing, In-Process QC testing and Finished Product QC testing for the preparation of Process Validation reports.  Perform other duties as requested by management.

 

Cleaning Validation Engineer / Specialist: will review/develop cleaning processes to ensure strict accordance with documentation; Summarize and evaluate cleaning validation findings in a clear, orderly, and succinct manner; Perform cleaning validation sampling, using standard operating procedures, to evaluate cleaning procedures.  Perform other duties as requested by management.

 

Requirements

  • Able and willing to travel to China
  • Excellent written and oral communication skills in English; communication skills in Chinese is a plus, but not necessary
  • 4 year degree in an applicable technical area, such as Biology, Chemistry or Engineering
  • At least 3 years of experience in a biological, biotechnology or pharmaceutical manufacturing environment
  • Knowledge of GMP facilities and cGMP requirements
  • Previous experience in the validation of biological products
  • Leads a project team for the development, execution and summarization of Process Validation protocols, IQ/OQ/PQ protocols, and reports.
  • Knowledge of statistical methods and previous experience utilizing statistical rationale for the verification of critical quality attributes and critical process parameters
  • Knowledge of Microsoft Windows, Word and Excel are mandatory
  • The ability to work effectively with team members and work under minimal supervision
  • Able and willing to work flexible hours

Job Specifics:

  • Long term project duration
  • Bonuses awarded at 6 month intervals
  • All expenses paid per contractual agreement
  • Flights paid per contractual agreement
  • Housing accommodation provided (Western type facilities)

 Click to apply and submit your resume

OR

E-Mail resume and cover letter to hr@validation.org or fax to (858) 673-3677