Sr Validation Engineer

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: Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development execution and management of commissioning qualification and validation (CQV) documents and protocols for highly specialized facility utility analytical and process equipment. The Senior Validation Engineer utilizes a broad range of engineering disciplines to ensure seamless progression from construction to clinical development and commercial GMP operations. Responsibilities include onboarding advanced technologies (such as isolator-based sterile systems) guiding process development supporting GMP operations managing investigation and CAPA processes driving continuous improvement initiatives and supporting future facility expansion projects.

Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
Serve as validation subject matter expert for the commissioning and qualification of a 60000 sq. ft. office warehouse and GMP Radiopharmaceutical production facility including isolator-based aseptic processes.
Lead the strategy and implementation of CQV programs for GMP spaces: office warehouse development quality control sterility/microbiology and GMP production with emphasis on isolator and containment technologies.
Direct and coordinate consultant(s) and project teams in the execution of validation activities and continuous improvement initiatives.
Partner cross-functionally with Engineering QC and Operations to develop and implement new processes and onboarding of new technologies including advanced isolator systems.
Provide senior-level validation oversight and support for ongoing development and GMP manufacturing operations.
Guide mentor and cross-train team members to broaden validation capabilities including process validation cleaning validation CSV and QC asset validation.
Own and drive key validation areas and projects establishing and maintaining best practices for isolator technology and sterile operations.
Lead complex deviation investigations data reviews CAPA management change controls and ensure robust technical documentation.
Author review and approve GMP documentation including SOPs forms protocols technical documents reports deviations CAPA and change controls.
Support and represent the validation function during Health Authority inspections and audits.
Monitor and report on department KPIs to drive performance improvement.
Execute and provide technical support for equipment and process validation including hands-on experience with isolator-based sterile filling and process systems.

Education and Experience
BS or MS in a scientific discipline or engineering field (advanced degrees preferred).
Minimum 5 years of experience in radiopharmaceutical or injectable GMP manufacturing environment.
Minimum 5 years of validation experience in GMP environments with direct isolator technology and aseptic processing experience required.

Skills and Qualifications
Advanced technical writing and documentation skills.
Expert knowledge of regulatory guidelines for validation risk management and isolator-based processes.
Proven leadership capabilities independent mindset and effective problem-solving abilities.
Highly organized professional with exceptional communication interpersonal and mentoring skills.
Track record of leading teams and cross-functional projects in GMP environments.
Strong multi-disciplinary engineering background with specific expertise in isolator systems for sterile manufacturing.
High professional ethics integrity and ability to maintain confidential information.

Work Environment
The noise level in the work environment is usually moderate.

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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.

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