Validation Engineer 1

Job description

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/ The Validation Engineer I supports the Radiopharmaceutical facility and GMP operations in Indianapolis. This role assists with the drafting and execution of commissioning, qualification, and validation (CQV) documents and protocols that support specialized facility, utility, analytical, and process equipment. Working under the guidance of senior team members, the Validation Engineer I contributes to validation activities that support the transition from construction to clinical development and ongoing GMP commercial operations. Additional responsibilities may include supporting new technology onboarding, process development, deviation investigations, CAPA activities, continuous improvement initiatives, and facility expansion projects. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Support the project team and/or General Contractor, as needed, in commissioning and validation activities for GMP and supporting spaces. Assist in the development and implementation of CQV strategies for office, warehouse, development, quality control, sterility/microbiology, and GMP production areas. Partner with consultants and cross-functional teams to support the implementation and execution of the CQV program. Provide validation support for day-to-day development and GMP operations. Execute or support equipment, utility, and process qualification activities as required. Assist with drafting GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, and change controls. Review data and documentation to support investigations and validation packages. Contribute to continuous improvement projects and assigned validation initiatives. Build knowledge in additional areas of validation such as process validation, QC assets, computer system validation, and cleaning validation. Support department KPI tracking and inspection readiness activities. Provide engineering and operational support as needed. Education and Experience Bachelor’s degree in engineering, life sciences, or a related scientific field, or equivalent work experience. 0-2 years of experience in a GMP manufacturing environment, preferably in radiopharmaceutical or injectable manufacturing. Exposure to validation, commissioning, qualification, or related technical support activities is preferred. Skills and Qualifications Basic technical writing skills. Foundational understanding of validation principles, GMP requirements, and risk management concepts. Strong attention to detail, organization, and willingness to learn. Effective interpersonal and communication skills. Ability to work collaboratively in a cross-functional GMP environment. Demonstrated professionalism, integrity, and ability to handle confidential information appropriately. Problem-solving mindset with the ability to follow direction and grow into increased technical ownership. Use AI tools to enhance individual productivity and quality of work Physical Demands While 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 Environment The 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: $82,236 - $99,650 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 Squibb RayzeBio 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. Supporting People with Disabilities BMS and RayzeBio are dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/a