Mold Validation Engineer

Katalyst HealthCares & Life Sciences

Job-ID32857021Reference26-01457 Primary Responsibilities: Executes mold trials (Functional Test, Gate Freeze, D3, Characterization) Captures RJG data & defines validated process windows Updates PODs & FW redlines Prepares draft OQ/PQ plans Coordinates daily with Healthcare ME, Ops, Quality, and Tooling Approves POD redlines & validation documents Ensures compliance with QMS & regulatory standards Run trials, collect RJG data, set process windows Prepare PODs, FW redlines, OQ/PQ drafts Coordinate with Healthcare teams Define mold validation scope Approve validation approach, parameters, PODs Provide templates (OQ, PQ, FW forms, POD format) Confirm press allocation and trial windows Review all trial results Participate in technical decisions (e.g., process window changes) Approve POD redlines Approve OQ/PQ draft documents Provide sign-off on validation readiness Qualification: Mold engineer -Mold qualification skills required. BE/master's in relevant to mechanical/Polymer/Industrial /Production . Exp range: 8 -12 years Please look for hands on experience in Mold Validation role in Medical Device Industries. Healthcare. Client. Boston Scientific. Client. Stryker. Baxter. Cardinal Health.

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