Principal Technical Operations Engineer (Radiopharmaceuticals)
Core
Leading and managing the development, implementation, and continuous improvement of processes within radiopharmaceutical operations to ensure product quality, regulatory compliance, and operational efficiency.
Role type
Principal Technical Operations Engineer (Radiopharmaceuticals)
Builds
Master Batch Records, Master Packaging Records, and compliant radiopharmaceutical manufacturing processes
Domain
Healthcare / Nuclear Medicine / Radiopharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, Corrective and Preventive Actions (CAPA) management, Change Control execution, Risk Management, Process optimization, Regulatory compliance (ISO 13485, 21 CFR 820), Technical documentation, Data analysis for process monitoring, Subject Matter Expertise, Process troubleshooting
Preferred skills
Engineering or Chemistry degree, Nuclear environment experience, Physical strength to manage up to 25 pounds
Technologies
None explicitly stated
Responsibilities
Lead creation and optimization of operational processes for radiopharmaceuticals; Manage and resolve Non-Conformance Reports (NCRs); Initiate and manage Corrective and Preventive Actions (CAPAs); Oversee Change Control processes; Serve as SME for process-related questions; Assist operations in troubleshooting and implementing process changes; Identify and implement data analysis to monitor process performance; Perform Risk Management Plan activities and Risk Assessments; Develop innovative technical solutions for difficult process problems
Seniority
Principal, hands-on IC with mentorship
