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Sr. Validation Specialist

Job City: Philadelphia
Job State: US - Pennsylvania
Client Project Number: 9276


The Validation Specialist will develop validation protocols and reports.   Will compile data packs and analyze data for adherence to established acceptance criteria. Typical processes that require validations are Vaccine Downstream Operations including unit operations such as filtration, lyophilization, sterile filling, and visual inspection.  This individual will also be responsible for cleaning validation studies (Hold time, CCIT, ), and equipment qualification studies. 

Experience Requirements: 

Recent hands on experience executing a broad range of validation activities.  8 - 10 years minimum experience required.

Vaccine or Biotech or Biologics Downstream manufacturing experience ( Vial or Syringe Sterile Filing ).  In depth knowledge of vial or syringe filing equipment, sufficient enough to identify critical process parameters and generate detailed validation protocol requirements.  

Test Method Validation is a plus.

Excellent Verbal and written communication skills. Ability to work in a team environment.

Education: BS/MS in Engineering, Life Science or Physical Science


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