Senior Validation Engineer — GMP Radiopharma CQV Lead

Biopharma Careers; Indianapolis (IN); On-site; USD 108,000 - 131,000; Full time

Benefits offered by this job

Health Coverage

401(k) plan

Employee Assistance Program (EAP)

Paid Time Off

Job summary

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Senior Validation Engineer to lead CQV efforts for a large GMP facility, develop validation strategies, and support health authority inspections. The role emphasizes strong technical writing, GMP experience, and collaboration across engineering, QC, and operations.

The candidate will own validation scopes, review data for investigations, and contribute to continuous improvement, with a focus on process validation, cleaning validation, and CSV.

Qualifications

• Proven ability to write GMP/validation documentation clearly and accurately.
• Strong understanding of validation, risk management, and regulatory guidelines.
• Independent, tenacious, and well-organized with excellent communication skills.
• Experience working in GMP environments with cross-functional teams.

Responsibilities

• Support commissioning and validation of 60,000 sq ft office, warehouse, and GMP production facility.
• Develop and implement CQV strategies for GMP spaces including multiple areas.
• Provide validation support for day-to-day development and GMP operations.
• Draft GMP documentation such as SOPs, protocols, deviations, CAPAs, and change controls.

Skills

Technical writing

Regulatory knowledge

Independent mindset

Motivated professional

GMP teamwork

GMP experience

Professional ethics

AI productivity tools

Education

BS/MS in science or related field

Job description

RayzeBio, a Bristol Myers Squibb subsidiary, seeks a Senior Validation Engineer to lead CQV efforts for a large GMP facility, develop validation strategies, and support health authority inspections. The role emphasizes strong technical writing, GMP experience, and collaboration across engineering, QC, and operations.

The candidate will own validation scopes, review data for investigations, and contribute to continuous improvement, with a focus on process validation, cleaning validation, and CSV.