Validation Engineer
Job Title: Validation Engineer
Location: Albany, NY
Type: Contract
Overview:
We're looking for a Validation Engineer to support ongoing operations at a leading pharmaceutical manufacturing facility. This role focuses on fill-finish equipment including automated syringe assembly machines, serialization lines, and cartoner modules.
Key Responsibilities:
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Execute validation activities throughout the equipment lifecycle, including FAT, SAT, Commissioning, DQ, IQ, OQ, and PQ
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Apply GAMP 5 methodology within a GMP-regulated environment
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Support Greenfield project efforts and equipment startup
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Prepare and manage validation documentation and deliverables
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Handle deviations, change controls, and CAPAs
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Collaborate closely with QA, Engineering, and Manufacturing teams
Required Experience:
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Direct experience with fill-finish equipment such as syringe assembly machines, serialization lines, and cartoners
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Strong working knowledge of GAMP 5 and the full validation lifecycle
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Previous involvement in Greenfield projects
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Proven ability to manage validation documents, deviations, CAPAs, and change controls
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Strong communication and technical writing skills
This is a hands-on, highly collaborative role suited for someone with deep knowledge of validation in a GMP setting and a track record of working with complex fill-finish systems.
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