VALIDATION SPECIALISTS

Job Role: Validation Specialists

Location: Piscataway, NJ

Work in different stages of validation such as design, development, installation,

operational, and performance of Computer Systems, Software, Lab equipment and Medical

Devices. Adhere to quality, regulatory and GxP standards. Review and update IQ/OQ/PQ

Summary and Validation Final Reports. Review the SIT/UAT test cases and conduct pre

and post-approvals. Understand GAMP 5, 21 CFR part 11, and Computer System

Validation. Perform CAPA process, closed deviations. Perform GAP analysis and Root

Cause Analysis. Manage user change requests and change process. Author and update

SOP’s. Prepare, review, authorize & submit documentation for quality compliance to

regulatory authorities. Bachelor’s degree in Science, Technology, Engineering, or any

related field with 2 years of experience in the job offered or related occupation is required.

Work location: Piscataway, NJ and various unanticipated locations throughout the U.S.

Send Resume to HR Dept., Stark Associates, LLC. DBA Stark Associates Business

Services, LLC., 15 Corporate Place South, Suite 350, Piscataway, NJ 08854.