Get job as soon as 2 days (HURRY UP) ENROLL NOW or Call   +1 (804)-454-3215
+

Computer Validation Engineer


Job ID : 27901

Location : Multiple Locations

Company Name : NASCENT GLOBAL LLC

Job Type : Contract

Industry : Healthcare

Salary : $30 - $45  per hour

No. of Positions : 10+


Required Skills : MES, Delta V, PI, IT SOP’s, GMP , SOX, Forms For IT Compliance, CSV, Data Management

Benefits : Medical Insurance,Dental Insurance,Life Insurance


Job Description :

The Computer Systems Validation (CSV) Engineer will develop and execute protocols and test scripts, identify gaps, and consult on and direct plans for resolution. This person is responsible for writing GxP computer validation and 21 CFR Part 11 related documentation such as assessments, plans, URS, FRS, RTM, and summary reports.

Requirements Include

  • BS in a Computer Science or Engineering field or equivalent experience
  • Experience with Computer systems validation in the USA
  • Experience working in a GMP environment
  • Experience in Data Integrity with GAMP and 483, compliance, consent decree experience, deep 21CFR Part 11 experience is highly desired
  • Experience in biotech and pharma is preferred over medical device
  • Experience with MES, Delta V, PI is a plus. 
  • Excellent oral and written communication skills in English/Fluent in English Develop IT SOP’s, Forms for IT compliance, CSV, data management (transfer and exchange of data in clinical studies), data integrity, It security, CSV Awareness and in depth knowledge of CSV (GxP), especially clinical.
  • Ability to work with business to complete new and retrospective
  • System impact assessments.
  • Update and manage system inventory
  • Support CSV projects as back up when needed Support inspection preparation
  • Knowledge of SOX, It security and infrastructure would be advantageous
  • Understanding of modern and risk based validation executions.
  • Knowledge of underlying infrastructure requirements supporting GxP systems a plus.
  • 5+ years working in CSV or Quality role supporting computerized systems.
  • Background in Life sciences and/or Pharma/Biotech industrie

Latest Jobs For You

  • Project Engineer

    Journey Group Sioux Falls, SD

    Essential Duties and Responsibilities: Assist the Project Manager with project procurement, ...

    View Job
  • Software/Database Developer

    CSL SOFTWARE SOLUTIONS Burlington, VT

    Ideal Experience/Skills: Knowledgeable in SQL, preferably Microsoft Transact-SQL Server 2012....

    View Job
  • Entry Level Computer Programmer

    Revature Chattanooga, TN

    Job Requirements: College degree (Associates or Bachelors) Must be authorized to work in the...

    View Job
  • Software Developer - Entry Level

    360 View Nashville, TN

    Job Description: Looking for talented graduates who are hungry to be challenged and grow their...

    View Job
  • Electrical Engineer – Entry and Mid-Level

    Elliott Bay Design Group Entry, WV

    Responsibilities & Duties: Work will primarily be in an office environment (5 days per ...

    View Job

Thanks For Your Feedback

We’re an equal opportunity provider.
All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
OPTnation.com is not a Consulting Company/Training Company/H1B Sponsor.