Senior Validation Engineer, Sterility & CQV
About The Position
The Senior Validation Engineer, CQV Sterility Assurance supports RayzeBio’s radiopharmaceutical facility and GMP operations in Indianapolis. The role develops, executes, and maintains commissioning, qualification, and validation documentation and strategies for facilities, utilities, analytical and laboratory equipment, sterility assurance, and process systems. It supports validation lifecycle activities in aseptic manufacturing, including environmental monitoring, cleanroom performance qualification, analytical laboratory instrumentation, and GMP study execution. The engineer collaborates with Quality, Manufacturing, Engineering, QC, Operations, consultants, contractors, and project teams to ensure systems, equipment, and processes are qualified, remain in a validated state, and comply with regulatory requirements, company procedures, and contamination-control expectations. The role also provides validation support for routine development, GMP manufacturing, laboratory, and operational activities; supports investigations and inspections; drafts GMP documentation; and mentors and cross-trains colleagues.
Requirements
- BS or MS in a 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 environments.
- 4–8 years of validation experience within a GMP environment.
- Good technical writing skills.
- 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.
- Independent mindset, tenacity, sound judgment, and attention to detail.
- Highly motivated and organized, 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 and integrity, and ability to maintain confidential information.
Nice To Haves
- Experience drafting, executing, or reviewing qualification and validation protocols.
Responsibilities
- Work with project teams, the General Contractor, consultants, and cross-functional partners on commissioning, qualification, and validation activities for GMP and supporting spaces, including offices, warehouses, 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 and 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 development, GMP manufacturing, laboratory, and operational activities, including troubleshooting, data review, investigation support, and validation impact assessments.
- Expand expertise in process validation, QC assets, cleaning validation, sterility assurance, and analytical equipment qualification.
- Own and manage assigned validation areas or project workstreams and support maintenance of the validated state.
- 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 documents, including 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 team members.
- Execute and support equipment and process validations as necessary.
Benefits
- Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and insurance offerings such as medical, dental, vision, life, and disability.
- Flexible Time Off (FTO) without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
- 160 hours of paid vacation annually for new hires for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico, subject to manager approval.
- 11 paid company holidays annually.
- Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
- Depending on eligibility, 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.
- Annual Global Shutdown between Christmas Day and New Year's Day for eligible employees.
- Potential eligibility for additional discretionary incentive cash and stock opportunities.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
