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Validation Systems Engineer


Job Id : 5644

Jobtitle : Validation Systems Engineer

Location : Princeton, NJ

Company Name : APLOMB Technologies

Industry : Information Technology

Salary : $35,490 - $84,970  YEAR

Job type : Fulltime

Posted on: 2019-10-16


Required Skills : Troubleshooting Skill, Documentation Skills, SoftMax Pro GxP, Analytical Skill

Benefits : No benefits are available


Job Responsibilities:

  • Design, authorize, and execute Computerized System Validation (CSV) -according to GAMP 5 guidance - especially on Analytical Laboratory Test Equipment and other Lab Information Systems.
  • Write validation documents (Risk Assessment, Validation Plan, Design Configuration/Specification, User Requirements, Functional Requirements, IQ OQ PQ Trace Matrix, Validation Summary Report), SOPs, Maintenance Procedures, Calibration Procedures, and other instrument support documents)
  • Execute Electronic Records/Electronic Signatures, Security test scripts, system and acceptance testing.
  • Analyze the results of testing and determining the acceptability of results against pre determined criteria.
  • Translate technical information and requirements into qualification/validation test design
  • Performing validation activities according to pharmaceutical FDA guidelines following GMPs, 21CFR Part 11, USP 1058, ASTM E2500, EU Annex 11, Data Integrity/ALCOA guidelines, GxP and ISO regulations - and other relevant industry regulations and guidance
  • Execute softwares Unicorn chromatography skids, SoftMax Pro GxP, Laboratory Information Management Systems (LIMS), Master Control, Track Wise, and Empower etc.
  • Investigate and troubleshoot problems which occur and determine solutions or recommendations for changes and/or improvements
  • Follow all relevant Quality, Health and Safety procedures and assist in incident investigations as required

 

Qualification:

  • Aplomb has a position of Validation Systems Engineer which requires a minimum of Bachelor s Degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a bachelor s degree in one of the aforementioned subjects

 

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