Validation Engineer II

Swiftwater, PA

Posted: 09/04/2019 Industry: Biotech/R&D/Science Job Number: 49483

Duties: 

Responsible for development and execution of improvement projects for Biologics Manufacturing.  Responsibilities include determining project scope, use of lean/FMEA/statistical and other methods to perform preliminary options analysis, change control development and execution, commissioning and qualification documentation development and execution, validation documentation development and execution, project tracking and completion activities.  Ability to interact with end users to gather business requirements and information to be translated into project requirements and deliverables.  Ability to interface between operations and support functions and is expected to work effectively with partner functions such as Quality and Manufacturing Technology.  

Skills: 
  • Must possess strong analytical and  communication  skills. 
  • Experience  writing and reviewing documents following Good Documentation  Practices. 
  • Experience  working in a cGMP  environment 
  • Must  be Proficient in use of Microsoft Outlook, Word and  Excel 
  • Experience  with  Microft  Project,  Trackwise  and statistical analysis software (SAS, JMP)  preferred 
  • Biologics  or Pharmaceuticals experience preferred 

Education: 
  • Technical Degree 
  • 3-6 years' experience 

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

Marion Bowden

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