VetJobs is hiring: Validation Engineer II - Indianapolis, IN in Indianapolis

Job Summary

Validation Engineer II will help support the Radiopharmaceutical facility and GMP operations in Indianapolis. The role is responsible for drafting and executing commissioning, qualification, and validation (CQV) documents and protocols that support the use of highly specialized facility, utility, analytical, and process equipment. The position utilizes a wide range of engineering disciplines to support the advancement from construction to clinical development and subsequent GMP commercial operations. Additional responsibilities may include onboarding new technologies, process development, GMP operations support, deviation investigation, CAPA management, continuous improvement projects, and future facility expansion projects.

Responsibilities

• Work with the project team and/or General Contractor to support 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) to support implementation and execution of the CQV program.
• Support the engineering, QC, and Operations team to improve and implement new processes.
• Provide validation support for day‑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.

Qualifications

• High School/GED required.
• BS or MS in a 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 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 position requires working in a GMP cleanroom environment, wearing protective clothing, and handling radioactive materials.

Compensation Overview

Indianapolis - RayzeBio - IN: $96,148 - $116,508

Seniority Level

Mid‑Senior level

Employment Type

Full‑time

Job Function

Quality Assurance

EEO Statement

VetJobs is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, veteran status, or any other protected status.