Validation Engineer

Location: Indianapolis

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA with development and GMP operations in Indianapolis, IN. Having raised over $250M since company launch in late 2020, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.

Job Description

The Validation Engineer will help support the establishment of a new Radiopharmaceutical facility and GMP operations in Indianapolis.  The Validation Engineer will be responsible for the drafting and executing commissioning, qualification, and validation (CQV) documents and protocols which support the use of highly specialized facility, utility, analytical, and GMP 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, and future facility expansion projects.

Job Responsibilities

  • Work with the project team and/or General Contractor as required 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 but not limited to office, warehouse, development, quality control, sterility/microbiology, and GMP production areas.
  • Work with consultant(s) as required to support the implementation and execution of the CQV program. 
  • Support the engineering, QC, and Operations team as required to improve and implement new processes
  • Provide validation support for day-to-day development and GMP operations
  • Draft GMP documentation, protocols, technical documents, reports, deviations and CAPAs as required
  • Provide engineering and operational support as required

EDUCATION/EXPERIENCE/SKILLS

Education and Experience:

  • BS/MS in Engineering, Science, or relevant field
  • 3-5 years of validation experience within a GMP environment required
  • Radiopharmaceutical experience preferred
  • Familiarity and knowledge of hotcell equipment and design

Skills:

  • Highly motivated and organized professional with the ability to work independently
  • Multi-disciplined engineer with GMP experience
  • Solid understanding of ICH guidelines for validation and risk management
  • Very personable with strong communication skills
  • Excellent professional ethics, integrity, and ability to maintain confidential information

Compensation: Competitive base salary with bonus, stock options, and full benefits

To apply please send CV to  kadkins@rayzebio.com.