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Validation & Engineering Group, Inc. · 1 month ago

ATL01-120825 Validation Specialist GA

Duluth, GA

Full-time

Onsite

Mid, Senior Level

3+ years exp

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Pharmaceutical and Medical Devices. They are seeking a Validation Specialist with strong CQV experience to manage equipment qualification and validation activities, ensuring compliance with industry standards.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Develop and execute validation deliverables including URS, ERES assessments, FAT/SAT protocols, IQ/OQ/PQ, POQ, and traceability matrices

Plan, manage, and perform equipment qualification and process validation activities following a risk-based CQV approach

Support qualification of general production and laboratory equipment used in medical device manufacturing

Apply risk management practices including functional risk documents, assessments, and pFMEAs

Execute and manage computerized system validation activities (PLC, HMI, Part 11 requirements, and integration testing)

Prepare high-quality validation documentation, circulate for review, and incorporate feedback to ensure right-first-time submissions

Investigate deviations during execution and manage resolution and documentation of root cause and corrective actions

Track documentation cycles, deviations, deliverable status, and project progress versus schedule

Communicate effectively with internal and client teams and escalate challenges that may affect schedule or deliverables

Provide status updates as required

Qualification

CQV experienceEquipment qualificationProcess validationComputerized system validation21 CFR Part 82021 CFR Part 11ISO 13485Risk management practicesMicrosoft WordMicrosoft ExcelMicrosoft ProjectKneatDocumentation skillsAttention to detailEffective communicationCollaboration skills