Validation Engineer

Company Overview

At Rayze Bio, every day is an opportunity to ignite meaningful change. We develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer.

• Support the project team and/or General Contractor in commissioning and validation activities for GMP and supporting spaces.
• Assist in the development and implementation of CQV strategies for office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Partner with consultants and cross‑functional teams to support the implementation and execution of the CQV program.
• Provide validation support for day‑to‑day development and GMP operations.
• Execute or support equipment, utility, and process qualification activities as required.
• Assist with drafting GMP documentation, including SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, and change controls.
• Review data and documentation to support investigations and validation packages.
• Contribute to continuous improvement projects and assigned validation initiatives.
• Build knowledge in additional areas of validation such as process validation, QC assets, computer system validation, and cleaning validation.
• Support department KPI tracking and inspection readiness activities.
• Provide engineering and operational support as needed.

• Bachelor’s degree in engineering, life sciences, or a related scientific field, or equivalent work experience.
• 0‑2 years of experience in a GMP manufacturing environment, preferably in radiopharmaceutical or injectable manufacturing.
• Exposure to validation, commissioning, qualification, or related technical support activities is preferred.

• Basic technical writing skills.
• Foundational understanding of validation principles, GMP requirements, and risk management concepts.
• Strong attention to detail, organization, and willingness to learn.
• Effective interpersonal and communication skills.
• Ability to work collaboratively in a cross‑functional GMP environment.
• Demonstrated professionalism, integrity, and ability to handle confidential information appropriately.
• Problem‑solving mindset with the ability to follow direction and grow into increased technical ownership.
• Use AI tools to enhance individual productivity and quality of work.

Regularly sit, reach with hands and arms, and talk or hear. Occasionally lift up to 30 pounds. Requires close and distance vision. Must work in a GMP cleanroom environment, wearing protective clothing, and handling radioactive materials.

The noise level is usually moderate.

Indy, Indiana: $82,236 – $99,650 annually. Additional incentive cash and stock opportunities may be available based on eligibility.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs.
• Financial Protection: 401(k), short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, liability protection.
• Work‑life benefits:
  Paid Time Off, unlimited sick time, volunteer days, summer hours flexibility, leaves of absence, annual global shutdown.

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BMS and Rayze Bio will consider qualified applicants with arrest and conviction records pursuant to applicable laws.

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