Validation Specialist

North Brunswick, NJ 08902

Posted: 08/01/2019 Industry: Biotech/R&D/Science Job Number: 49341

Duties: 

We have a well-defined methodology for validation of computerized systems and equipment, based on the GAMP standard. We’ re looking for an individual to lead an implementation of this methodology at the R&D site in North Brunswick NJ.  

Major activities include: 
  • Create an implementation plan consistent with global policies. Create local or functional procedures and guidelines if needed. 
  • Inventory  existing local systems. Assess gaps and create system review reports including mitigation  plans. 
  • For systems identified as high priority for remediation, and for new installations and/or major changes. 
  • Lead cross-functional teams including subject matter experts, IT support, and quality assurance to drive creation of validation documents using approved templates and processes.  

Skills: 

  • The individual must be a skilled writer, proficient in MS Office, with experience gathering requirements from users to create validation documents. 

Education: 
  • at least 4 years of relevant experience with a Ph.D. or M.S. 
  • at least 6 years of relevant experience with a B.S. 

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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