Senior CQV Sterility Engineer – Validation Leader

Regulatory Jobs; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Job summary

RayzeBio in Indianapolis, IN, seeks a Senior Validation Engineer, CQV Sterility Assurance to lead commissioning, qualification, and validation efforts across facility systems and analytical labs. You will partner with Quality, Manufacturing, Engineering, and QA to ensure validated state and regulatory compliance in aseptic radiopharmaceutical operations.

The role requires 4–8 years in GMP environments, strong technical writing, and hands-on CQV experience with analytical instrumentation such as

Qualifications

• BS or MS in a scientific field or equivalent experience.
• 4-8 years in Radiopharmaceutical, injectable, sterile manufacturing, aseptic processing, analytical lab or GMP environment.
• Experience drafting, executing, or reviewing qualification/validation protocols.

Responsibilities

• Support commissioning, qualification, and validation activities for GMP spaces and related areas.
• Develop, implement, and maintain CQV strategies for facility, utilities, analytical, laboratory, sterility, and process systems.
• Support environmental monitoring programs, aseptic simulations, cleanroom qualification, and related validation studies.
• Execute qualification for laboratory and analytical equipment (HPLC/UPLC, GC, UV-Vis, TOC, particle counters, endotoxin testing, microbiology equipment).
• Provide validation support for day-to-day development and GMP manufacturing activities, including troubleshooting and CAPA impact assessments.
• Expand expertise to process validation, QC assets, cleaning validation, sterility assurance, and analytical equipment qualification.
• Own and manage validation areas or project workstreams and maintain validated state.
• Investigate deviations and review data for investigations, CAPA closures, and change controls.
• Draft GMP documentation (SOPs, forms, protocols, reports, deviations, change controls).
• Support inspections, internal audits, KPI tracking, and training of team members.
• Execute equipment and process validations as needed.

Skills

Technical writing

Regulatory guidelines

GMP compliance

CQV principles

Sterility assurance

Environmental monitoring

Risk management

Data analysis

Team collaboration

Problem solving

Education

BS or MS in scientific field

Tools

HPLC/UPLC

Gas Chromatographs

UV-Vis spectrophotometers

TOC analyzers

Particle counters

Endotoxin testing instruments

Microbiology lab equipment

Job description

RayzeBio in Indianapolis, IN, seeks a Senior Validation Engineer, CQV Sterility Assurance to lead commissioning, qualification, and validation efforts across facility systems and analytical labs. You will partner with Quality, Manufacturing, Engineering, and QA to ensure validated state and regulatory compliance in aseptic radiopharmaceutical operations.

The role requires 4–8 years in GMP environments, strong technical writing, and hands-on CQV experience with analytical instrumentation such as