Validation Engineer II

Validation Engineer II – Bristol Myers Squibb (Rayze Bio), Indianapolis, IN

The Validation Engineer II will support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role will draft and execute commissioning, qualification, and validation (CQV) documents and protocols for specialized facility, utility, analytical, and process equipment, covering construction to clinical development and GMP commercial operations. Additional responsibilities may include onboarding of new technologies, process development, GMP operations support, deviation investigation, CAPA management, continuous improvement, and future facility expansion projects.

• Work with the project team and/or General Contractor to support the commissioning and validation of a 60,000 sf office, warehouse, and GMP Radiopharmaceutical production facility.
• Develop and implement the CQV strategies for GMP spaces including office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
• Collaborate with consultants to support the implementation and execution of the CQV program.
• Support the engineering, QC, and Operations teams to improve and implement new processes.
• Provide validation support for day‑to‑day development and GMP operations.
• Offer engineering and operational support as required.
• Expand expertise in additional validation areas (process validation, QC assets, CSV, cleaning validation, etc.).
• Own and manage a specific validation area (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 departmental KPIs related to performance.
• Mentor and cross‑train other team members.
• Execute and provide support for equipment and process validations as necessary.

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

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

The employee must regularly sit, reach, lift and/or move up to 30 pounds, and handle tasks in a GMP cleanroom environment wearing protective clothing and handling radioactive materials. Specific vision abilities include close and distance vision.

The noise level is usually moderate.

Indianapolis – Rayze Bio – IN: $96,148 – $116,508 annual base salary. Incentive cash and stock opportunities may be available. Final compensation is determined based on experience.

• Health Coverage:
  Medical, pharmacy, dental, and vision care.
• Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs.
• Financial Well‑being: 401(k) plan, short‑ and long‑term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Paid Time Off:
  Flexible with unlimited paid time off subject to manager approval; additional vacation, holidays, and optional holidays based on location.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations, and ongoing support. Applicants can request accommodations prior to accepting an offer. For more about accommodations, contact

BMS is an Equal Opportunity Employer. These statements apply to all aspects of employment and are in addition to any other rights afforded under federal or state law.