LCSr. Validation Engineer; Project Consultant
Listed on 2025-12-15
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Engineering
Process Engineer, Quality Engineering
LC01-120925 Sr. Validation Engineer (Project Consultant) – Validation & Engineering Group, Inc.
Location: Remote (preferred near Minnesota – Chaska area)
Travel: Occasional travel to Miami, Cincinnati/Kentucky area, and vendor sites
Duration: 6–12 months (Contract)
Reports To: Sr. Director, Project Management
Industry: Biotechnology / Diagnostics
Position OverviewThe 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).
- 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%).
- Familiarity with regulated environments (GMP/ISO 13485).
- Project coordination or project management experience.
- Remote with visits to Minnesota (Chaska) and Cincinnati/Kentucky/Miami as needed.
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