LC01-120925 Sr. Validation Engineer (Project Consultant)
Share
Job Location:
Chaska, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
7 hours ago
Vacancies:
1 Vacancy
Job Summary
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: 612 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 (1525%).
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
Required Experience:
Senior IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
