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 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 workstreams 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 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 work
Physical 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.
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 the applicable plans in effect at the time and may require enrollment. Our benefits include:
- Health Coverage: Medical, pharmacy, dental, and vision care.
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include:Paid Time Off
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
*Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.
RayzeBio and Bristol Myers SquibbRayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.
