This job has closed.

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. is a leading services supplier providing solutions for various industries including Biotechnology. They are seeking a Senior Validation Engineer (Project Consultant) to support the transition of diagnostic equipment and processes, focusing on lab automation and operational readiness.

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

Equipment transitionsLab automationRisk assessmentChange managementProject managementVendor coordinationGMP/ISO 13485 familiarityCommunication skillsLeadership skillsCross-functional teamwork