Lead Validation Engineer

Lead Validation Engineer – Rayze Bio

Rayze Bio, a wholly‑owned subsidiary of Bristol Myers Squibb, is committed to developing transformative radiopharmaceutical therapies for patients with cancer. The Lead Validation Engineer will support the Radiopharmaceutical facility and GMP operations in Indianapolis, serving as a technical leader for commissioning, qualification, and validation activities.

• 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, QC, 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.

• 5+ years of experience in a radiopharmaceutical, injectable, or other regulated GMP manufacturing environment.
• 5+ 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.

• BS or MS in a scientific or engineering discipline, or equivalent work experience.
• Broad validation knowledge across areas such as process validation, cleaning validation, computer system validation, equipment qualification, and QC assets.
• 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 multiple initiatives in a fast‑paced GMP environment.
• High level of professional ethics, integrity, and confidentiality.
• Applies AI to improve team execution and decision‑making.

The employee must sit, reach with hands and arms, and talk or hear. Occasional lifting or moving up to 30 pounds is required.

Noise level is usually moderate. The position requires working in a GMP cleanroom environment, wearing protective clothing, and handling radioactive materials.

Compensation for this role in Indianapolis ranges from $124,449 to $150,803 per year, plus potential incentive cash and stock opportunities. Benefits include medical, pharmacy, dental, and vision care; a 401(k) plan; paid time off; and various wellness and employee assistance programs.

BMS and Rayze Bio are committed to equal employment opportunity and encourage qualified applicants from all backgrounds to apply.