| Validation Engineer in Southern NH (EAD or GC or Citizen)_Hybrid at Remote, Remote, USA |
| Email: [email protected] |
| From: Bhuwan Tiwari, Sonitalentcorp [email protected] Reply to: [email protected] Job Title Validation Engineer Location Southern NH (Hybrid) Duration of project 6 months+ Required visa Any visa (Except H1B and CPT) Mode of Interview Video or Onsite Only local (No Relocation) Project description: This is a new client tech transfer into an existing cell therapy asset (2K). Existing and new equipment needs to be validated and this includes bioreactors, autoclaves, freezers, incubators and associated utilities. Will be a 1-2 year project and there will be the opportunity to support secondary projects. The first phase of this tech transfer is starting in August 2024 and the goal is to have the project team established by September. The current size of the team is 5-7 and is a mix of FTE and consultant resources. Will be working with a larger cross functional team that includes engineering, manufacturing and quality. This resource will increase the teams bandwidth and will be primarily supporting temperature mapping and CSV activities initially. Technology environment the consultant will be working in: Kneat DeltaV MODA Consultants day to day responsibilities: Execution of IQ and OQ protocols on existing biologics manufacturing equipment including bioreactors, incubators, CIP/SIP systems and autoclaves Temperature mapping and thermal uniformity testing of upgraded and new equipment using Kaye. Documentation of test results. Assessing change controls for process equipment and automation systems to ensure they meet requirements to maintain validated status. Reviewing and approving SOPs, change controls, deviation reports and all supporting documentation. Execution of CSV protocols for associated commercial software systems including LIMS, MES and Master Control Root cause analysis of any discrepancy reports generated during validation execution and proposing CAPAs Required Skills: Bachelors degree in life sciences or engineering 5+ years of validation experience in a cell and gene therapy GMP environment. Prior validation experience supporting a tech transfer project. Previous experience with temperature mapping using Kaye equipment (Validator and ValProbe systems. Previous experience executing IQ, OQ, PQ on cell and gene therapy equipment in a GMP environment. Some examples include: Bioreactors, Mixing tanks, Distribution Systems, Autoclave, Incubators, Refrigerators, Freezers, HPLC, TFF, Ultra filtration, Autoclaves and CIP/SIP. Prior experience using Kneat validation software in a GMP environment. Thanks, Bhuwan Tiwari Sr.Technical Recruiter SoniTalent Corporation I 5404 Merribrook Lan--e, Prospect, KY, USA Cell -859-946-4062 | [email protected] Keywords: Kentucky New Hampshire Validation Engineer in Southern NH (EAD or GC or Citizen)_Hybrid [email protected] |
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| Tue Aug 06 00:19:00 UTC 2024 |