Principal Technical Operations Engineer (Radiopharmaceuticals)

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.

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 drive 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