Validation Engineers

Job Description:

  • Plan and prepare validation plan tests and qualification protocols for manufacturing processes, systems, equipment for production of pharmaceuticals products.
  • Perform GAMP 5 risk based validation and Prepare IQ/OQ/PQ, validation plan, test cases, system/module risk assessment.
  • Perform corrective and preventive actions (CAPA) in the scope of a retrospective validation. Perform risk-based prioritization and unique predefinitions of tasks.
  • Maintain test results Deviation log and ensure that the deviations are closed in the stipulated time.
  • Travel to various unanticipated locations in the US to interact with clients for short or long terms assignments 

Salary:                                    $125,008 /year

Work Schedule:          8:30 am-5:30pm; 40 Hrs/week (M-F)

 Requirements:             BS or foreign equivalent in Pharmaceutical Sc., Biotechnology, Chemistry or related + 5 yrs of exp as Validation Analyst, QA Analyst or related, performing Gamp 5 Risk based validation and using Trackwise, HP Quality Center, and QTP 11.  The Employer will also accept MS or foreign equivalent in Pharmaceutical Sc., Biotechnology, Chemistry or related + 1 yr of exp as Validation Analyst, QA Analyst or related, performing Gamp 5 Risk based validation and using Trackwise, HP Quality Center, and QTP 11

Job Location:             270 Davidson Avenue, 1st Floor Suite 111, Somerset, NJ 08873

To apply contact:        Santhosh Kinnera, IT Project Manager

hr@tk-chain.com

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