Lead Validation Engineer, GMP Radiopharma

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Benefits offered by this job

Health coverage

Wellbeing programs

401(k) plan

Paid time off

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Lead Validation Engineer to support its Radiopharmaceutical facility in Indianapolis and GMP operations. You will oversee commissioning, qualification, and validation activities across diverse systems, driving continuous improvement and regulatory readiness.

The role requires strong technical writing, leadership, and cross-functional collaboration with engineering, QC, and operations, mentoring engineers and ensuring quality

Qualifications

• BS or MS in a scientific or engineering discipline, or equivalent work experience.
• 5+ years in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment.
• 5+ years of validation experience within a GMP-regulated environment.
• Demonstrated experience leading complex validation programs and cross-functional initiatives.
• Prior experience mentoring engineers or leading project workstreams preferred.

Responsibilities

• Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs.
• Develop, implement, and improve commissioning, qualification, and validation strategies for GMP and non-GMP spaces (office, warehouse, development, QC, sterility/microbiology, production).
• Partner with project teams, consultants, Quality, Engineering, QC, and Operations to deliver validation milestones.
• Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting and risk assessments.
• Own and manage complex validation programs and ensure timely execution of protocols and reports.

Skills

Technical leadership

Technical writing

Problem solving

Cross-functional collaboration

Regulatory compliance

Project management

Independent work

Communication

Risk assessment

Education

BS or MS in science/engineering

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Lead Validation Engineer to support its Radiopharmaceutical facility in Indianapolis and GMP operations. You will oversee commissioning, qualification, and validation activities across diverse systems, driving continuous improvement and regulatory readiness.

The role requires strong technical writing, leadership, and cross-functional collaboration with engineering, QC, and operations, mentoring engineers and ensuring quality