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LC01-120925 Sr. Validation Engineer

2 weeks ago

Chaska, Minnesota, United States Validation & Engineering Group Full time

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

  • Project Consultant � Equipment Transition & Laboratory Automation

Location: Remote (preferred near Minnesota � Chaska area)

Travel: Occasional travel (Miami, Cincinnati/Kentucky area, and vendor sites)

Duration: 6�12 months (Contract)

Reports To: Sr. Director, Project Management

Industry: Biotechnology / Diagnostics

Position Overview

The Project Consultant will support the transition of diagnostic equipment, processes, and reagent filling operations within a leading biotechnology diagnostics organization. This role focuses on lab automation assets, operational readiness, and risk assessment related to equipment deployment, relocation, and qualification.

The consultant will work cross-functionally with engineering, operations, quality, and supplier stakeholders to ensure seamless integration of systems and processes across multiple sites.

Key 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).

Qualifications

  • 5+ years� experience in biotech/diagnostics or life sciences manufacturing environments.

  • Experience with equipment transitions, lab automation, or reagent/filler equipment strongly preferred.

  • Knowledge of risk assessment methodologies and change management best practices.

  • Ability to work effectively in virtual/remote cross-functional teams.

  • Strong communication, leadership, and vendor coordination skills.

  • Flexibility to travel as required (15�25%).

Preferred Experience

  • Familiarity with regulated environments (GMP/ISO

  • Project coordination or project management experience.

Travel Details

  • Remote with visits to Minnesota (Chaska) and Cincinnati/Kentucky/Miami as needed