Lead Radiopharmaceutical Process Engineer

RXinsider LTD.; Indianapolis (IN); On-site; USD 81,000 - 116,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401k savings plan

Paid time off

Job summary

Cardinal Health is seeking a Principal Technical Operations Engineer (Radiopharmaceuticals) to lead development, implementation, and continuous improvement of radiopharmaceutical processes, ensuring quality, regulatory compliance, and operational efficiency.

You will act as SME for process questions, manage NCRs, CAPAs, and Change Controls, and help create Master Batch Records for onboarding clients to the CMC facility.

Qualifications

• 4-8 years of experience in related field preferred.
• Bachelor's, Master's or PhD in Engineering or Chemistry preferred.
• Comfortable working in a nuclear environment.
• Ability to lift up to 25 pounds.

Responsibilities

• Applies knowledge to perform tasks and projects in radiopharmaceutical processes.
• Leads creation and optimization of operational processes for radiopharmaceuticals with ISO 13485 and 21 CFR 820 alignment.
• Manages NCRs by investigating root causes and implementing corrective actions.
• Initiates and manages CAPAs for process deviations and improvements.
• Oversees Change Control processes ensuring proper documentation and regulatory compliance.
• Serves as SME for process questions and trains operations teams.
• Assists operations in troubleshooting and implementing process changes.
• Identifies opportunities for process improvements to reduce waste and improve quality.
• Uses data analysis to monitor process performance and drive changes.
• Supports QA, QC, PM teams with process expertise and compliant documentation.
• Contributes to Risk Management Plans and risk assessments for process-related risks.
• Develops innovative technical solutions aligned with organizational goals.
• Completes tasks independently after general guidance on new projects.

Skills

Nuclear environment experience

Process improvement

Regulatory compliance

CAPA management

Education

Engineering or Chemistry degree

Job description

Cardinal Health is seeking a Principal Technical Operations Engineer (Radiopharmaceuticals) to lead development, implementation, and continuous improvement of radiopharmaceutical processes, ensuring quality, regulatory compliance, and operational efficiency.

You will act as SME for process questions, manage NCRs, CAPAs, and Change Controls, and help create Master Batch Records for onboarding clients to the CMC facility.