Validation Engineer II

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high‑achieving teams. Take your career farther than you thought possible.

The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer II will be responsible for drafting and executing commissioning, qualification, and validation (CQV) documents and protocols that support the use of highly specialized facility, utility, analytical, and process equipment. The position will utilize a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations.

Additional responsibilities may include the onboarding of new technologies, process development, GMP operations support, deviation investigation, CAPA management, continuous improvement projects, and future facility expansion projects.

• Work with the project team and/or General Contractor to support the commissioning and validation of a 60,000‑sq‑ft office, warehouse, and GMP Radiopharmaceutical production facility.
• Develop and implement the CQV strategies for the GMP spaces including office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Work with consultant(s) to support the implementation and execution of the CQV program.
• Support the engineering, QC, and Operations team to improve and implement new processes.
• Provide validation support for day‑to‑day development and GMP operations.
• Provide engineering and operational support as required.
• Expand expertise in additional areas of validation (process validation, QC assets, CSV, cleaning validation, etc).
• Own and manage a specific area of validation (e.g., process validation, QC assets, CSV, cleaning validation, etc).
• Apply technical knowledge to investigate manufacturing deviations.
• Review data and documentation to support investigations.
• Own and drive projects and continuous improvement efforts.
• Draft GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPAs, change controls, and reports.
• Support Health Authority Inspections.
• Maintain department KPIs related to performance.
• Mentor and cross‑train other team members.
• Execute and support equipment and process validations as necessary.

• BS or MS in a scientific related field or equivalent work experience.
• 2–5 years of experience in a Radiopharmaceutical or injectable GMP manufacturing environment.
• 2–5 years of validation experience within a GMP environment.

• Good technical writing skill set.
• Solid understanding of regulatory guidelines for validation and risk management.
• Independent mindset and tenacity.
• Highly motivated and organized professional with strong interpersonal and communication skills.
• Proven experience working with teams in a GMP environment.
• Multi‑disciplined engineer with GMP experience.
• Excellent professional ethics, integrity, and ability to maintain confidential information.

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

The noise level in the work environment is usually moderate.

Indianapolis – Rayze Bio – IN: $96,148 – $116,508. The starting compensation range is listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided…