Validation Engineer

New Yesterday

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: Execute validation activities throughout the equipment lifecycle, including FAT, SAT, Commissioning, DQ, IQ, OQ, and PQ
Apply GAMP 5 methodology within a GMP-regulated environment
Support Greenfield project efforts and equipment startup
Prepare and manage validation documentation and deliverables
Handle deviations, change controls, and CAPAs
Collaborate closely with QA, Engineering, and Manufacturing teams
Required Experience: Direct experience with fill-finish equipment such as syringe assembly machines, serialization lines, and cartoners
Strong working knowledge of GAMP 5 and the full validation lifecycle
Previous involvement in Greenfield projects
Proven ability to manage validation documents, deviations, CAPAs, and change controls
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.
Location:
New York