Senior Validation Engineer - Radiopharma GMP Leader

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

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary, is hiring a Lead Validation Engineer in Indianapolis to guide commissioning, qualification and validation across GMP facilities. You will lead cross-functional teams, draft and review validation protocols, and drive CAPA and continuous improvement initiatives.

The role requires a BS or MS in science or engineering, 5+ years in a regulated GMP setting, and proven leadership in complex validation programs.

Qualifications

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

Responsibilities

• Lead cross-functional validation activities for facility, utility, equipment, analytical, and process validation programs.
• Develop and implement commissioning, qualification, and validation strategies for GMP and non-GMP spaces.
• Provide technical leadership for day-to-day GMP manufacturing support, including risk assessments and validation impact assessments.
• Review and approve validation documents, SOPs, protocols, and deviation/CAPA documentation.
• Mentor validation engineers and support regulatory inspections with validation strategies and documentation.

Skills

Technical leadership

GMP validation

Documentation & writing

Cross-functional collaboration

Risk assessment

Project management

Education

BS or MS in science or engineering

Job description

RayzeBio, a Bristol Myers Squibb subsidiary, is hiring a Lead Validation Engineer in Indianapolis to guide commissioning, qualification and validation across GMP facilities. You will lead cross-functional teams, draft and review validation protocols, and drive CAPA and continuous improvement initiatives.

The role requires a BS or MS in science or engineering, 5+ years in a regulated GMP setting, and proven leadership in complex validation programs.