Principal Technical Operations Engineer (Radiopharmaceuticals)

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

Job Summary

The Principal Technical Operations Engineer (Radiopharmaceuticals) is responsible for leading and managing the development, implementation, and continuous improvement of processes within radiopharmaceutical operations. This role is critical for ensuring product quality, regulatory compliance, and operational efficiency. The Principal Technical Operations Engineer will serve as a Subject Matter Expert (SME) for all process-related questions, actively manage Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Controls, and directly assist operations to achieve excellence in radiopharmaceutical manufacturing and support. The Principle Engineer will also create new processes such as Master Batch Records for clients as they onboard to the CMC facility.

Responsibilities

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects related to radiopharmaceutical processes.


• Leads the creation, optimization, and documentation of new and existing operational processes for radiopharmaceuticals, ensuring alignment with ISO 13485 and 21 CFR 820 Quality System Regulations.


• Manages and drives the resolution of Non-Conformance Reports (NCRs) by investigating root causes, implementing corrective actions, and ensuring process adjustments prevent recurrence.


• Initiates, investigates, and manages Corrective and Preventive Actions (CAPAs) related to process deviations, quality issues, and operational improvements, ensuring timely and effective closure.


• Oversees and executes the Change Control process for radiopharmaceutical operations, ensuring all proposed changes to processes, equipment, or materials are properly documented, assessed, approved, and implemented in compliance with regulatory requirements.


• Serves as the primary Subject Matter Expert (SME) for all process-related questions, providing guidance and training to operations teams and cross-functional partners.


• Actively assists operations in troubleshooting process issues, implementing process changes, and ensuring consistent execution of established procedures.


• Involves in continuous improvement activities, identifying opportunities for process enhancements that increase efficiency, reduce waste, and improve product quality within radiopharmaceutical operations.


• Identifies and implements data analysis to monitor process performance, ensure finished goods meet standards and specifications, and drives necessary changes to operational processes.


• Supports Operations, Quality Control, Quality Assurance and Program Management teams by providing process expertise and ensuring process documentation supports compliance.


• Performs activities related to Risk Management Plan, Risk Assessments with a focus on process-related risks in radiopharmaceutical production such as Master Batch Records and Master Packaging Records.


• May contribute to the development of policies and procedures directly impacting radiopharmaceutical operations and process control.


• Develops innovative technical solutions to a wide range of difficult process problems encountered in radiopharmaceutical manufacturing and support. Solutions are consistent with organization objectives.


• Completes tasks independently after receiving general guidance on new projects or operational challenges.

Qualifications

• 4-8 years of experience, preferred


• Bachelor\'s, Masters, or PhD in Engineering or Chemistry is preferred.


• Comfortable working in a nuclear environment


• Ability to manage up to 25 pounds

What is expected of you and others at this level

• Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.


• May contribute to the development of policies and procedures.


• Works on complex projects of large scope.


• Develops technical solutions to a wide range of difficult problems.


• Solutions are innovative and consistent with organization objectives.


• Completes work; independently receives general guidance on new projects.


• Work reviewed for purpose of meeting objectives.


• May act as a mentor to less experienced colleagues.

Anticipated salary range

$80,900.00-$115,500.00

Bonus eligible: No

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage


• Paid time off plan


• Health savings account (HSA)


• 401k savings plan


• Access to wages before pay day with myFlexPay


• Flexible spending accounts (FSAs)


• Short- and long-term disability coverage


• Work-Life resources


• Paid parental leave


• Healthy lifestyle programs

Additional information

Application window anticipated to close: 09/14/2026 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.