LC01-120925 Sr. Validation Engineer (Project Consultant) at Validation & Engineering Group

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 AutomationLocation: 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 ManagementIndustry: Biotechnology / DiagnosticsPosition 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 ResponsibilitiesLead 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).Qualifications5 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 ExperienceFamiliarity with regulated environments (GMP/ISO 13485).Project coordination or project management experience.Travel DetailsRemote with visits to Minnesota (Chaska) and Cincinnati/Kentucky/Miami as neededRequired Experience:Senior IC Key Skills Python,SOC,Debugging,C/C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing Employment Type : Contract Experience: years Vacancy: 1