Validation Engineer
Prowess IT Solutions LLC
East Brunswick, NJ
Full-time
Engineering
Posted on January 8, 2023
Validation Engineer - Prowess IT Solutions LLC - East Brunswick, NJneeded w/ Masters of Bus. Admin deg. or Foreign Equiv in Healthcare Mgmt or Healthcare Administration or Pharmacy or Pharmaceutical Sciences & 6 mths exp as Validation Engr or Qlty Coordinator performing following job duties: Resp for the comp. system validation to dvlp, plan, draft, implmt & document User Acceptance Testing for LIMS used for GLP purpose. Test plan, data migration plan, test protocol, acceptance criteria, test script for IQ, OQ, PQ specs for Systems incl LIMS, Veeva Vault QMS & Trackwise. Dvlp Validation Summary Report (VSR) & work w/ chromatography systems, HPLC, autoclaves, incubators, freezers & coolers. Change control process under Trackwise end-to-end process & handle PV activities. Perform Instrument/ Eqpmt qualification of Validation of Microplate reader, UV-VIS & Densitometer Analytical Instruments usage in Systems & eqpmt, Thermal Mapping Lab. Eqpmt, Packaging Eqpmt & Process Eqpmt. Maintain Validation Master Plans. Use 21 CFR Part 11 drug cGxP. Job Locs.: East Brunswick, NJ or unanticipated client sites w/in the U.S. Must be available to travel & relocate to unanticipated client sites for temp. projects. Mail Resumes to: Prowess IT Solutions LLC, 2 Brier Hill Ct, 2B Bldg F, East Brunswick, NJ 08816.