LC01-120925 Sr. Validation Engineer (Project Consultant)

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 13485).

• Project coordination or project management experience.

Travel Details

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