Validation Engineer Jobs in Indiana (NOW HIRING)

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/

Summary

The Senior Validation Engineer will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Senior Validation Engineer will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the use of highly specialized facility, utility, analytical, and process equipment. The position will utilize a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations. Additional responsibilities may include the onboarding of new technologies, process development, GMP operations support, deviation investigation, CAPA management, continuous improvement projects, and future facility expansion projects.

Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Work with the project team and/or General Contractor as required to support the commissioning and validation of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility.
• Develop and implement the CQV strategies for the GMP spaces including but not limited to office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Work with consultant(s) as required to support the implementation and execution of the CQV program.
• Support the engineering, QC, and Operations team as required to improve and implement new processes
• Provide validation support for day-to-day development and GMP operations
• Provide engineering and operational support as required
• Expand expertise in additional areas of validation (process validation, QC assets, CSV, cleaning validation, etc)
• Own and manage a specific area of validation (i.e. process validation, QC assets, CSV, cleaning validation, etc)
• Apply technical knowledge and abilities to investigate manufacturing deviations
• Review data and documentation to support investigations
• Own and drive projects and continuous improvement efforts
• Draft GMP documentation including but not limited to SOP's, Forms, Protocols, Technical Documents, Reports, Deviations, CAPAs, Change Controls and reports.
• Support Health Authority Inspections
• Maintain department KPIs related to performance
• Mentor and cross-train other team members
• Execute and provide support executing equipment and process validations as necessary.

Education and Experience

• BS or MS in scientific related field or equivalent work experience
• 4-8 years of experience in Radiopharmaceutical or injectable GMP manufacturing environment
• 4-8 years of validation experience within a GMP environment

Skills and Qualifications

• Good technical writing skill-set
• Solid understanding of regulatory guidelines for validation and risk management
• Must possess an independent mindset and tenacity
• Highly motivated and organized professional with strong interpersonal and communication 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 thisjob, 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 thisjobincludeclose vision and distance vision.

This is a position that requires working in a GMP cleanroom environment, wearing protective clothing, and handling of radioactive materials.

WorkEnvironment

The noise level in theworkenvironment 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.

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 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 toadastaffingsupport@bms.com. Visitcareers.bms.com/eeo-accessibilityto 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:https://careers.bms.com/california-residents/

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 https://careers.bms.com/fraud-protection/

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. 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.