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Validation & Engineering Group, Inc. · 1 month ago

LC01-120925 Sr. Validation Engineer (Project Consultant)

Chaska, MN

Full-time

Hybrid

Senior Level

5+ years exp

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. They are seeking a Sr. Validation Engineer (Project Consultant) to support the transition of diagnostic equipment and lab automation processes, focusing on operational readiness and risk assessment related to equipment deployment.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Lead and coordinate projects for equipment and process transfers across diagnostic labs and operations

Support transition of lab automation equipment

Oversee filler and reagent equipment readiness, integration, and operational qualification planning

Conduct risk assessments and mitigation planning for equipment relocation and manufacturing continuity

Support development and execution of transition schedules, RACI, and communication plans

Track and report project progress, risks, and critical decisions to the Sr. Director and leadership teams

Coordinate with supplier partners on technical interfaces, upgrades, and delivery timelines

Ensure alignment with quality, validation, and safety requirements throughout transition activities

Prepare and maintain project documentation (status reports, dashboards, meeting minutes, action logs)

Qualification

Biotech/diagnostics experienceEquipment transitionsLab automationRisk assessment methodologiesProject coordinationVendor coordinationChange managementCommunication skillsLeadership skills