Apply on Employer Site

Validation & Engineering Group, Inc. · 3 months ago

ATL01-092425 Validation Specialist – Laboratory CQV & Method Validation - GA

Duluth, GA

Full-time

Onsite

Mid, Senior Level

5+ years exp

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a skilled Validation Engineer to support laboratory equipment qualifications and analytical method validations for new products in production, requiring strong technical expertise and attention to detail.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Plan, author, and execute qualification protocols (IQ/OQ/PQ) for new laboratory instruments, including TruScans and balances

Develop and execute validation protocols for ~11 analytical methods (e.g., Gas Chromatography, UV-Vis Spectroscopy, Karl Fischer Titrations)

Generate and revise validation documentation (protocols, reports, SOPs, specifications) in compliance with cGMP standards

Conduct investigations for deviations, perform root cause analysis, and implement corrective actions

Ensure compliance with Good Documentation Practices (GDP) and “right the first time” deliverables

Collaborate with cross-functional teams (QA, Engineering, Production) and communicate project status to stakeholders

Support change control management and risk assessment activities

Qualification

Laboratory equipment qualificationMethod validationValidation documentationKneat validation systemRisk-based qualificationMicrosoft WordMicrosoft ExcelMicrosoft ProjectComputerized system validationMedical device manufacturingTechnical writingCommunication skillsProblem-solving skills