Validation Engineer

Validation Engineer I

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio 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.

The Validation Engineer I supports the Radiopharmaceutical facility and GMP operations in Indianapolis. This role assists with the drafting and execution of commissioning, qualification, and validation (CQV) documents and protocols that support specialized facility, utility, analytical, and process equipment. Working under the guidance of senior team members, the Validation Engineer I contributes to validation activities that support the transition from construction to clinical development and ongoing GMP commercial operations.

Additional responsibilities may include supporting new technology onboarding, process development, deviation investigations, CAPA activities, continuous improvement initiatives, and facility expansion projects.

Essential duties and responsibilities include the following. Other duties may be assigned.

• Support the project team and/or General Contractor, as needed, 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

While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 30 pounds. Specific vision abilities required by this job include close vision and distance vision.

This position requires working in a GMP cleanroom environment, wearing protective clothing, and handling radioactive materials.

The noise level in the work environment is usually…