Senior Validation Engineer, Sterility & CQV

Bristol Myers Squibb; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Flexible Time Off (FTO)

11 paid holidays

160 hours vacation for new hires

Job summary

RayzeBio in Indianapolis is seeking a Senior Validation Engineer, CQV Sterility & CQV, to draft, execute, and maintain qualification and validation documentation for GMP facilities and processes. You will collaborate with Quality, Manufacturing, Engineering, and project teams to ensure systems remain validated and compliant.

The role covers aseptic manufacturing environments, environmental monitoring, analytical equipment qualification, and validation study execution.

Qualifications

• BS or MS in scientific related field (or equivalent work experience).
• 4-8 years of Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical lab, or GMP environment experience.
• Experience drafting, executing, or reviewing qualification and validation protocols is preferred.

Responsibilities

• Support commissioning, qualification, and validation activities for GMP and supporting spaces (office, warehouse, development, QC, sterility/microbiology, GMP production).
• Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, sterility, and process systems.
• Support environmental monitoring programs, aseptic process simulations/media fills, cleanroom qualification, and validation studies.
• Execute qualification activities for laboratory/analytical equipment (HPLC/UPLC, GC, UV-Vis, TOC, particle counters, endotoxin testing, microbiology equipment).
• Provide validation support for development, GMP manufacturing, lab and operations activities including data review and CAPA impact assessments.
• Expand expertise to process validation, QC assets, cleaning validation, sterility assurance, and equipment qualification.
• Own and manage assigned validation areas or project streams while maintaining validated state.
• Investigate manufacturing, lab, and validation deviations and support investigations.
• Draft GMP documents: SOPs, forms, protocols, reports, deviations, CAPAs, change controls, test scripts and summaries.
• Support inspections, audits, and KPI tracking related to validation performance and compliance.
• Mentor and cross-train team members; execute equipment/process validations as needed.

Skills

Technical writing

Regulatory guidelines

GMP

CQV principles

Environmental monitoring

Analytical instrumentation

Risk management

Team collaboration

Problem solving

Education

BS or MS in scientific related field

Tools

HPLC/UPLC

Gas chromatographs

UV-Vis spectrophotometers

TOC analyzers

Particle counters

Endotoxin testing instruments

Microbiology equipment

Job description

Life at BMS

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 Senior Validation Engineer, 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

• 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.
• 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, injectable, sterile manufacturing, aseptic processing, analytical laboratory, quality control, or GMP manufacturing environment
• 4-8 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
• Uses AI tools to enhance individual productivity and quality of work
• 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.

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.

Compensation Overview

Indianapolis - RayzeBio - IN $107,904 - $130,754

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https //careers.bms.com/benefits

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

Additional Information for California Residents

For roles based in Los Angeles County only 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 this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number.

R1607264 Senior Validation Engineer, Sterility & CQV