Lead Validation Engineer – GMP & Radiopharma

Bristol-Myers Squibb; Indianapolis (IN); On-site; USD 124,449 - 150,803; Full time

Benefits offered by this job

Health Coverage

Wellbeing Support

Financial Well-being

Job summary

RayzeBio in Indianapolis is seeking a Lead Validation Engineer to champion commissioning, qualification, and validation activities across a radiopharmaceutical facility. You will draft, review, and execute critical validation documents and support transitions from construction to clinical and commercial operations.

The role demands strong technical writing, regulatory understanding, and leadership to guide cross-functional teams through validation milestones, CAPAs, and continuous improvement.

Qualifications

• BS or MS in scientific or engineering discipline.
• 5+ years in a radiopharmaceutical, injectable, or GMP manufacturing environment.
• 5+ years of validation experience in a GMP setting.
• Experience leading complex validation programs and cross-functional initiatives.
• Mentoring engineers or leading project workstreams is preferred.

Responsibilities

• Lead cross-functional validation activities for facility, utility, equipment, analytical, computerised systems, cleaning, and process validation programs.
• Develop, implement, and continuously improve commissioning, qualification, and validation strategies for GMP and non-GMP spaces.
• Partner with project teams to deliver validation milestones aligned with objectives.
• Provide technical leadership for day-to-day GMP manufacturing support, including risk assessments.
• Review and approve validation documents, deviations, CAPAs, and change controls.
• Drive continuous improvement and support regulatory inspections.

Skills

Technical writing

Regulatory knowledge

Leadership

Communication

Project management

Independent work

Risk assessment

Education

BS or MS in scientific or engineering discipline

Job description

RayzeBio in Indianapolis is seeking a Lead Validation Engineer to champion commissioning, qualification, and validation activities across a radiopharmaceutical facility. You will draft, review, and execute critical validation documents and support transitions from construction to clinical and commercial operations.

The role demands strong technical writing, regulatory understanding, and leadership to guide cross-functional teams through validation milestones, CAPAs, and continuous improvement.