Validation Engineer, Sterility & CQV

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: **Summary** The Validation Engineer II, CQV Sterility Assurance supports the radiopharmaceutical facility and GMP operations in Indianapolis by drafting, executing, and maintaining commissioning, qualification, and validation documentation for facility, utility, analytical, laboratory, sterility assurance, and process systems. This role supports validation lifecycle activities for aseptic manufacturing environments, environmental monitoring programs, analytical laboratory instrumentation, cleanroom performance qualification, and GMP study execution. The position partners with Quality, Manufacturing, Engineering, QC, Operations, consultants, contractors, and project teams to ensure systems, equipment, and processes are qualified, maintained in a validated state, and aligned with applicable regulatory requirements, company procedures, and contamination control expectations. ## ## **Job Responsibilities** Essential duties and responsibilities include the following. Other duties may be assigned. - Work with the project team, General Contractor, consultants, and cross-functional partners as required to support commissioning, qualification, and validation activities for GMP and supporting spaces, including office, warehouse, development, quality control, sterility/microbiology, and GMP production areas. - Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, sterility assurance, and process systems. - Support environmental monitoring programs, aseptic process simulations/media fills, airflow visualization smoke studies, cleanroom performance qualification, disinfection and sanitization validation, and VHP/bio-decontamination studies. - Execute qualification activities for laboratory and analytical equipment, including HPLC/UPLC systems, gas chromatographs, UV-visible spectrophotometers, TOC analyzers, particle counters, endotoxin testing instruments, and microbiology laboratory equipment. - Provide validation support for day-to-day development, GMP manufacturing, laboratory, and operational activities, including troubleshooting, data review, investigation support, and validation impact assessments. - Expand expertise in additional areas of validation, including process validation, QC assets, cleaning validation, sterility assurance, and analytical equipment qualification. - Own and manage assigned validation areas or project workstreams while supporting validated state maintenance. - Apply technical knowledge and abilities to investigate manufacturing, laboratory, sterility assurance, and validation-related deviations. - Review data and documentation to support investigations, deviation closure, CAPA effectiveness, change control implementation, inspection readiness, and validated state maintenance. - Draft GMP documentation including but not limited to SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, change controls, test scripts, and summary reports. - Support Health Authority inspections, internal audits, and department KPI tracking related to validation performance, execution status, and compliance. - Mentor and cross-train other team members. ## ## **Education and Experience** - BS or MS in scientific related field or equivalent work experience - 2-5 years of experience in Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical laboratory, quality control, or GMP manufacturing environment - 2-5 years of validation experience within a GMP environment - Experience drafting, executing, or reviewing qualification and validation protocols is preferred ## ## **Skills and Qualifications** - Good technical writing skill-set - Solid understanding of regulatory guidelines for validation, lifecycle management, data integrity, documentation practices, and risk management - Working knowledge of GMP requirements, CQV principles, sterility assurance, contamination control, environmental monitoring, analytical laboratory instrumentation, and risk-based validation methodologies - Must possess an independent mindset, tenacity, sound judgment, and attention to detail - Highly motivated and organized professional with strong interpersonal, communication, problem-solving, data analysis, and planning skills. - Proven experience working with teams in a GMP environment. - Multi-disciplined engineer with GMP experience - Excellent professional ethics, integrity, and ability to maintain confidential information. - Uses 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 is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials. **Work Environment** The noise level in the work environment is usually moderate. #LI-Onsite *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: $96,148 - $116,508 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:** *T*he 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/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [adastaffingsupport@bms.com](mailto:adastaffingsupport@bms.com). Visit [](https://careers.bms.com/eeo-accessibility)[eeo](https://careers.bms.com/eeo-accessibility)[-accessibility](https://careers.bms.com/eeo-accessibility) to 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: **Data Protection** We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at Any 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 [TAEnablement@bms.com](mailto:TAEnablement@bms.com). 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. R1605491 : Validation Engineer, Sterility & CQV