Validation Engineer 1

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 youll 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 impacton our science on our teams and most importantly on patients. Learn more about RayzeBio: 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

• Bachelors 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 doesnt 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.

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 employees 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 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 workplaceaccommodations/adjustmentsand ongoing support in their roles. Applicants can request a reasonable workplaceaccommodation/adjustmentprior to accepting a job offer. If you require reasonableaccommodations/adjustmentsin completing this application or in any part of the recruitment process direct your inquiries to. Visit access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider for employment qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: Protection

We will never request payments financial information or social security numbers during our application or recruitment process. Learn more about protecting yourself at data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If you believe that the job posting is missing information required by local law or incorrect in any way please contact BMS at . Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response.