OT System Qualification & Validation Consultant (CSV Life Sciences) Indianapolis,IN (Onsite)

Overview

On Site
$60 - $70
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 12 Month(s)

Skills

OT System Qualification & Validationfor Life Sciences

Job Details

Role: OT System Qualification & Validation Consultant (CSV Life Sciences)
Location: Indianapolis,IN (Onsite)
Duration: 1+ Year Contract
pranayatburgeonitsdotcom

Job Description

We are looking for an experienced CSV Consultant with strong expertise in OT System Qualification & Validation for Life Sciences. The ideal candidate will have hands-on experience with Manufacturing, Quality, and Engineering systems, ensuring compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP5).

Key Skills Required

  • 10 12 years of IT Quality & Compliance / CSV experience.

  • Strong in OT System Qualification, PAS/DCS, Manufacturing Equipment Integration.

  • Knowledge of IT QMS, Risk Management, Deviations, CAPA, Test Management.

  • Exposure to MES, QMS (TrackWise), LIMS, Empower CDS, Chromeleon.

  • Hands-on with HP ALM, Kneat, SNOW (preferred).

Nice to Have

  • Experience with Radio Ligand Therapy or Critical Dosage Forms.

  • Understanding of ISA95 & OT Security.

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