Sr Validation Engineer

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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.

Summary
The Senior Validation Engineer will lead validation efforts to support the Radiopharmaceutical facility and GMP operations in Indianapolis. This role is responsible for the development, execution, and management of commissioning, qualification, and validation (CQV) documents and protocols for highly specialized facility, utility, analytical, and process equipment. The Senior Validation Engineer utilizes a broad range of engineering disciplines to ensure seamless progression from construction to clinical development and commercial GMP operations. Responsibilities include onboarding advanced technologies (such as isolator-based sterile systems), guiding process development, supporting GMP operations, managing investigation and CAPA processes, driving continuous improvement initiatives, and supporting future facility expansion projects.

Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
•    Serve as validation subject matter expert for the commissioning and qualification of a 60,000 sq. ft. office, warehouse, and GMP Radiopharmaceutical production facility, including isolator-based aseptic processes.
•    Lead the strategy and implementation of CQV programs for GMP spaces: office, warehouse, development, quality control, sterility/microbiology, and GMP production, with emphasis on isolator and containment technologies.
•    Direct and coordinate consultant(s) and project teams in the execution of validation activities and continuous improvement initiatives.
•    Partner cross-functionally with Engineering, QC, and Operations to develop and implement new processes and onboarding of new technologies, including advanced isolator systems.
•    Provide senior-level validation oversight and support for ongoing development and GMP manufacturing operations.
•    Guide, mentor, and cross-train team members to broaden validation capabilities, including process validation, cleaning validation, CSV, and QC asset validation.
•    Own and drive key validation areas and projects, establishing and maintaining best practices for isolator technology and sterile operations.
•    Lead complex deviation investigations, data reviews, CAPA management, change controls, and ensure robust technical documentation.
•    Author, review, and approve GMP documentation including SOPs, forms, protocols, technical documents, reports, deviations, CAPA, and change controls.
•    Support and represent the validation function during Health Authority inspections and audits.
•    Monitor and report on department KPIs to drive performance improvement.
•    Execute and provide technical support for equipment and process validation, including hands-on experience with isolator-based sterile filling and process systems.

Education and Experience
•    BS or MS in a scientific discipline or engineering field (advanced degrees preferred).
•    Minimum 5 years of experience in radiopharmaceutical or injectable GMP manufacturing environment.
•    Minimum 5 years of validation experience in GMP environments, with direct isolator technology and aseptic processing experience required.

Skills and Qualifications
•    Advanced technical writing and documentation skills.
•    Expert knowledge of regulatory guidelines for validation, risk management, and isolator-based processes.
•    Proven leadership capabilities, independent mindset, and effective problem-solving abilities.
•    Highly organized professional with exceptional communication, interpersonal, and mentoring skills.
•    Track record of leading teams and cross-functional projects in GMP environments.
•    Strong multi-disciplinary engineering background, with specific expertise in isolator systems for sterile manufacturing.
•    High professional ethics, integrity, and ability to maintain confidential information.

Work Environment
The noise level in the work environment is usually moderate.

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Compensation Overview:

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into