Validation Engineer II

Working With Us

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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. 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 Summary

The Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The Validation Engineer II 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 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.

Job Duties

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

• 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
• 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 (i.e. process validation, QC assets, CSV, cleaning validation, etc)
• Apply technical knowledge and abilities to investigate manufacturing deviations
• Review data and documentation to support investigations
• Own and drive projects and continuous improvement efforts
• Draft GMP documentation including but not limited to SOP's, 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 provide support executing equipment and process validations as necessary

Education and Experience

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

Skills and Qualifications

Good technical writing skill-set Solid understanding of regulatory guidelines for validation and risk management Must possess an 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.

Physical Demands

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

Work Environment

The noise level in the work environment is usually moderate.