Validation Engineer II - Indianapolis

Job Description

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Unless specifically stated otherwise, this role is "On-Site" at the location detailed in the job post.

At Rayze Bio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, Rayze Bio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do.

From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients.

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 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.

• 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.

466067

High School/GED

Engineering

• 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.

• 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…