Senior Validation Engineer – Radiopharmaceutical GMP Leader

Biopharma Careers; Indianapolis (IN); On-site; USD 124,000 - 151,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing and Work-life benefits

Paid Time Off

401(k) and retirement

Stock opportunities

Job summary

RayzeBio in Indianapolis is seeking a Lead Validation Engineer to support radiopharmaceutical GMP operations. You will lead commissioning, qualification, and validation activities for facility, utility, and equipment, while guiding cross-functional teams and ensuring regulatory alignment and lifecycle documentation.

You will mentor engineers, drive CAPA and deviation investigations, and partner with Quality, Engineering, and Operations to meet milestones.

Qualifications

• BS or MS in a scientific or engineering discipline or equivalent experience.
• 5+ years in a radiopharmaceutical, injectable, or other GMP manufacturing environment.
• 5+ years of validation experience in GMP environments.
• Demonstrated experience leading complex validation programs and cross-functional initiatives.

Responsibilities

• Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs.
• Develop and improve commissioning, qualification, and validation strategies for GMP and non-GMP spaces.
• Partner with project teams to deliver validation milestones aligned with compliance objectives.
• Provide technical leadership for day-to-day GMP manufacturing support, including troubleshooting and risk assessments.
• Own and manage complex validation programs and ensure timely execution of documents and reports.
• Review and approve validation documents including SOPs, forms, and CAPAs.
• Lead deviation investigations and root-cause analyses for validation and manufacturing systems.
• Drive continuous improvement projects to enhance compliance and efficiency.
• Mentor validation engineers and cross-functional staff.
• Support regulatory inspections and internal audits with validation rationale and documentation.

Skills

Technical leadership

Regulatory knowledge

Validation programs

GMP compliance

Cross-functional collaboration

Project management

Technical writing

Mentoring engineers

AI-enabled execution

Education

BS or MS in scientific or engineering discipline

Tools

Computerized systems

Job description

RayzeBio in Indianapolis is seeking a Lead Validation Engineer to support radiopharmaceutical GMP operations. You will lead commissioning, qualification, and validation activities for facility, utility, and equipment, while guiding cross-functional teams and ensuring regulatory alignment and lifecycle documentation.

You will mentor engineers, drive CAPA and deviation investigations, and partner with Quality, Engineering, and Operations to meet milestones.