Lead Validation Engineer

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio 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 Rayze Bio:

Summary

The 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 Responsibilities

Essential 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 Experience

* BS 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 work streams is strongly preferred.

Skills and Qualifications

* Strong 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…