Validation Engineer, Sterility & CQV

Bristol-Myers Squibb; United States; On-site; USD 80,000 - 105,000; Full time

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Validation Engineer II to drive CQV activities in Indianapolis. You will draft, execute, and maintain qualification documentation for facility, utilities, analytical, laboratory, sterility assurance, and process systems, ensuring GMP compliance.

You will work with Quality, Manufacturing, Engineering, and QC to qualify systems, perform environmental monitoring, and support audits and inspections.

Qualifications

• 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.

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.

Skills

Technical writing

Regulatory guidelines

GMP knowledge

Independent mindset

Problem solving

Teamwork GMP

Education

BS/MS in science

GMP validation experience

2-5 years radiopharmaceutical/ GMP

Experience drafting/exec validation protocols

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: https://careers.bms.com/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

• 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 eng