Senior Validation Engineer, Sterility & CQV

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 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 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.

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.
• Execute and provide support executing equipment and process validations as necessary.

• 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

• 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.

We hire for skills and capabilities not just credentials if this role excites you but doesnt perfectly match your resume we encourage you to apply anyway.

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 Years Day.

U.S.-based job seekers can explore full benefit offerings at 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 qualified applicants with arrest and conviction records pursuant to applicable laws in your area.

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