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Astrix Technology Group

Laboratory Validation Specialist

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What they do

A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.

$105,084 / year median in New York

+7% projected growth

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Job Description

We are seeking a Laboratory Validation Specialist to support validation and quality activities within a GMP-regulated pharmaceutical environment with a focus on lab equipment, API manufacturing processes, and validation lifecycle support.
Location:
Rensselaer, NY Pay:
$55-$78/hr
DOE Type:
Contract (Potential Extension/Conversion) Key Responsibilities Provide quality review and approval of validation activities related to equipment, systems, and process changes Develop, execute, and review IQ, OQ, and PQ validation protocols and reports Review and approve validation documentation, change controls, and deviation investigations Support root cause analysis and non-conformance resolution Ensure validated state of equipment through documentation and compliance review Support audits, inspections, and regulatory readiness activities Partner with QA, Engineering, and R&D on validation strategy and execution Maintain accurate validation records and support Annual Product Reviews (APR) Requirements 6+ years of validation, QA, or pharmaceutical/biotech manufacturing experience Strong experience with IQ/OQ/PQ and GMP environments Background in lab equipment validation and/or API manufacturing preferred Experience with change control, deviations, and audits Strong understanding of cGMP and FDA requirements Strong documentation and communication skills Nice to Have Experience in API or small molecule manufacturing Familiarity with LIMS, TrackWise, or similar quality systems This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you! INDBH #LI-CS1