Lc01 - 120925 Sr. Validation Engineer (project Consultant) - Remote Eligible

Project Consultant – Equipment Transition & Laboratory Automation

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.