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Sr. Validation Engineer - Packaging

Alcami • Clinton, TN, US • published 2026-09-26 09:51:26.215211

Description

: At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary: The Sr. Validation Engineer \- Packaging is responsible for leading validation and qualification activities that support compliant pharmaceutical packaging operations, including packaging equipment, utilities, facilities, and computerized systems. The Sr. Validation Engineer \- Packaging develops and executes validation protocols, maintains validation documentation, manages change controls, and ensures systems remain inspection\-ready and compliant with cGMP, data integrity, and 21 CFR Part 11 requirements. The position partners closely with engineering, quality, operations, IT, contractors, and equipment vendors to support the installation, qualification, and ongoing performance of packaging\-related equipment and systems. Additionally, the role serves as a validation subject matter expert during audits, provides technical guidance, authors SOPs and validation plans, and helps drive cont...

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