Principal Engineer, Technical Operations
Not Disclosed•Full-TimeOn-site
location_on3322, East Saint Clair Street, Rivoli Park, Near Eastside, Indianapolis, Marion County, Indiana, 46201, United States
About the Role
The Principal Technical Operations Engineer (Radiopharmaceuticals) serves as a critical Subject Matter Expert (SME) within our CMC facility, leading the development and continuous improvement of processes essential to radiopharmaceutical manufacturing. This role exists to ensure product quality, regulatory compliance, and operational excellence while directly supporting operations teams in achieving their goals.
In this position, you will manage the lifecycle of Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Controls. You will act as the primary resource for process-related inquiries, guiding operations and cross-functional partners through complex technical challenges. A key part of your day involves creating new Master Batch Records for clients as they onboard, troubleshooting process issues, and driving data analysis to monitor performance and ensure finished goods meet strict standards.
You will work independently on large-scale, complex projects, developing innovative technical solutions that align with organizational objectives. This role offers the opportunity to mentor less experienced colleagues and contribute to the development of policies that shape our operational landscape.
Work location
Work model: On-site
3322, East Saint Clair Street, Rivoli Park, Near Eastside, Indianapolis, Marion County, Indiana, 46201, United States
Indianapolis, Indiana
Key Responsibilities
- check_circleLead creation and optimization of radiopharmaceutical operational processes
- check_circleManage Non-Conformance Reports (NCRs) and drive root cause analysis
- check_circleInitiate and close Corrective and Preventive Actions (CAPAs) for process deviations
- check_circleServe as Subject Matter Expert for process-related questions and training
- check_circleDevelop innovative technical solutions for complex manufacturing problems
- check_circleSupport continuous improvement activities to increase efficiency and reduce waste
- check_circleAnalyze process data to monitor performance and ensure product specifications
- check_circleOversee Change Control processes for equipment, materials, and procedures
- check_circleCreate Master Batch Records for client onboarding to CMC facilities
- check_circleConduct Risk Management Plans and assessments for production processes
Requirements
- verified4-8 years of experience
- verifiedBachelor's, Masters, or PhD in Engineering or Chemistry
Nice to Have
4-8 years of experience. Bachelor's, Masters, or PhD in Engineering or Chemistry.
Benefits & Perks
check_circleMedical, dental and vision coveragecheck_circlePaid time off plancheck_circleHealth savings account (HSA)check_circle401k savings plancheck_circleAccess to wages before pay day with myFlexPaycheck_circleFlexible spending accounts (FSAs)check_circleShort- and long-term disability coveragecheck_circlePaid parental leave
Similar Job Opportunities
Senior Director, Global Product Strategy & Product Management
Accuray • Madison, Wisconsin
Not Disclosedarrow_forward
Engineering Technician - Injection Molding
Plastic Molding Manufacturing • Shelbyville, Indiana
Not Disclosedarrow_forward
Director of Operations - Manufacturing
Elgen Staffing • City of Rochester, New York
Not Disclosedarrow_forward