Rayzebio
Biotech
LeadValidationEngineer
“Lead Validation Engineer at Rayzebio. Skills: Validation, GMP, Radiopharmaceutical, Leadership. Lead validation activities for facility. Lead validation activities for utility”
What You'll Achieve.
Deliver validation milestones; Enhance compliance; Enhance efficiency; Enhance operational readiness
Industry & Context.
Problem-solving; Troubleshooting; Risk assessments; Root cause analysis
Work in GMP cleanroom, Wear protective clothing, Handle radioactive materials, Lift up to 30 pounds
What They're Looking For.
Must Have
BS or MS in scientific or engineering discipline, 8+ years experience in radiopharmaceutical, injectable, or regulated GMP manufacturing, 8+ years validation experience in GMP-regulated environment, Demonstrated experience leading complex validation programs, Demonstrated experience leading cross-functional initiatives
Nice to Have
Prior experience mentoring engineers, Prior experience leading project workstreams
What You'll Do.
Lead validation activities for facility
Lead validation activities for utility
Lead validation activities for equipment
Lead validation activities for analytical
Lead validation activities for computerized systems
Lead validation activities for cleaning
Lead validation activities for process validation
Develop commissioning strategies for GMP spaces
Develop commissioning strategies for non-GMP spaces
Implement commissioning strategies for GMP spaces
Implement commissioning strategies for non-GMP spaces
Improve commissioning strategies for GMP spaces
Improve commissioning strategies for non-GMP spaces
Develop qualification strategies for GMP spaces
Develop qualification strategies for non-GMP spaces
Implement qualification strategies for GMP spaces
Implement qualification strategies for non-GMP spaces
Improve qualification strategies for GMP spaces
Improve qualification strategies for non-GMP spaces
Develop validation strategies for GMP spaces
Develop validation strategies for non-GMP spaces
Implement validation strategies for GMP spaces
Implement validation strategies for non-GMP spaces
Improve validation strategies for GMP spaces
Improve validation strategies for non-GMP spaces
Partner with project teams
Partner with consultants
Partner with contractors
Partner with Engineering
Partner with Operations
Provide technical leadership for development support
Provide technical leadership for GMP manufacturing support
Manage complex validation programs
Ensure timely execution of protocols
Ensure timely execution of reports
Ensure timely execution of lifecycle documentation
Review validation documents
Approve validation documents
Lead deviation investigations
Support root cause analysis
Support corrective actions
Support preventive actions
Drive continuous improvement projects
Mentor validation engineers
Coach validation engineers
Develop validation engineers
Mentor cross-functional team members
Coach cross-functional team members
Develop cross-functional team members
Support regulatory inspections
Support internal audits
Track departmental KPIs
Communicate departmental KPIs
Communicate project status
Communicate project risks
Communicate resource needs
Support onboarding of new technologies
Support facility modifications
Support expansion projects
How You'll Work.
Team & Collaboration
Cross-functional teams; Project teams; Consultants; Contractors; Quality; Engineering; QC; Operations
Communication Scope
Communication; Organization
Process & Methodology
Project management
Applying for this Lead Validation Engineer role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Rayzebio?
Real rants from real employees. Read before you apply.