Lead Validation Engineer

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/SummaryThe Lead Validation Engineer will support the Radiopharmaceutical facility and GMP operations in Indianapolis and serve as a technical leader for commissioning, qualification, and validation activities. This role is responsible for leading the drafting, review, and execution of commissioning, qualification, and validation documents and protocols supporting highly specialized facility, utility, analytical, and process equipment. The position applies broad engineering and GMP knowledge to support the transition from construction to clinical development and commercial operations, while also providing leadership in process improvement, deviation investigation, CAPA management, new technology implementation, and future expansion initiatives.Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.Lead cross-functional validation activities for facility, utility, equipment, analytical, computerized systems, cleaning, and process validation programs.Develop, implement, and continuously improve commissioning, qualification, and validation strategies for GMP and non-GMP spaces including office, warehouse, development, quality control, sterility/microbiology, and production areas.Partner with project teams, consultants, contractors, Quality, Engineering, QC, and Operations to deliver validation milestones aligned with business and compliance objectives.Provide technical leadership for day-to-day development and GMP manufacturing support, including troubleshooting, risk assessments, and validation impact assessments.Own and manage complex validation programs and ensure timely execution of protocols, reports, and lifecycle documentation.Review and approve validation documents including SOPs, forms, protocols, technical reports, deviations, CAPAs, change controls, and summary reports.Lead deviation investigations and support root cause analysis, corrective actions, and preventive actions related to validation and manufacturing systems.Drive continuous improvement projects that enhance compliance, efficiency, and operational readiness.Mentor, coach, and develop validation engineers and cross-functional team members.Support regulatory inspections and internal audits by presenting validation strategies, rationale, and supporting documentation.Track and communicate departmental KPIs, project status, risks, and resource needs to leadership.Support onboarding of new technologies, facility modifications, and expansion projects as required.Education and ExperienceBS or MS in a scientific or engineering discipline, or equivalent work experience.8+ years of experience in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment.8+ 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 is strongly preferred.Skills and QualificationsStrong technical writing and document review skills.Deep understanding of regulatory expectations for validation, lifecycle management, and risk management.Strong leadership, decision-making, and problem-solving skills.Ability to work independently while effectively influencing cross-functional teams.Excellent communication, organization, and project management capabilities.Proven ability to prioritize multiple initiatives in a fast-paced GMP environment.Broad validation knowledge across areas such as process validation, cleaning validation, computer system validation, equipment qualification, and QC assets.High level of professional ethics, integrity, and ability to maintain confidential information.Uses AI tools to enhance individual productivity and quality of workPhysical DemandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.This position requires working in a GMP cleanroom environment, wearing protective clothing, and handling radioactive materials.Work EnvironmentThe noise level in the work environment is usually moderate.If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Indianapolis - RayzeBio - IN: $107,904 - $130,754 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of th