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Validation & Engineering Group, Inc. · 4 months ago

Validation Specialist (Upstream Process Equipment) LL04-250822

Juncos, 077

Full-time

Onsite

Mid, Senior Level

3+ years exp

Validation & Engineering Group, Inc. is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a CQV Specialist for Upstream Process Equipment who will be responsible for the commissioning and qualification of systems supporting cell culture operations in a cGMP biotechnology manufacturing environment.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Author, review, and execute commissioning and qualification protocols (IQ, OQ, PQ) for upstream equipment

Perform field inspections, verification activities, and system walkdowns

Support FAT/SAT execution with equipment vendors and engineering teams

Ensure systems are installed, configured, and performing according to URS, FS, and DS documentation

Troubleshoot equipment and resolve discrepancies or deviations during commissioning and qualification

Maintain traceability between user requirements, functional/design specifications, and testing protocols

Interface with automation, process engineering, QA, and manufacturing to drive schedule adherence and quality

Prepare and review summary reports, risk assessments, and impact assessments as part of the validation package

Qualification

CQV experienceValidation protocolsUpstream biotechnology processesElectronic systems proficiencyIndustry regulations knowledgeBachelor’s degreeSingle-use technology experienceProcess control systems knowledgeTech transfer exposure