✦ Luna Orbit — Engineering (Non-Software)

Principal Engineer, Technical Operations

at Cardinal Health

📍 IN-Indianapolis-Theranostics Commercial Unknown 💰 $80K – $115K USD / year Posted April 02, 2026
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Position Details

Salary $80K – $115K USD / year
Type Full-Time
Experience lead
Exp. Years 4-8 years
Education Bachelor's, Masters, or PhD in Engineering or Chemistry is preferred.
Category Engineering (Non-Software)

About this role

Principal Technical Operations Engineer leads radiopharmaceutical process development and continuous improvement, ensuring regulatory compliance and high product quality; SME for process-related questions and CAPA/NCR handling.

Key Responsibilities

  • Apply regulatory standards to processes
  • Lead NCRs and CAPAs
  • Manage Change Controls
  • Develop Master Batch/Packaging Records
  • Mentor operations teams

Technical Overview

Experience with ISO 13485, 21 CFR 820, NCR, CAPA, Change Controls, and Master Batch/Packaging Records; strong data analysis and risk management; works with regulatory bodies and CMOs.

Ideal Candidate

The ideal candidate is an experienced process engineer focused on radiopharmaceutical manufacturing with 4+ years of GMP/regulatory experience, ISO 13485 and 21 CFR 820 proficiency, and strong NCR/CAPA/Change Control capabilities.

Must-Have Skills

4-8 years of experienceBachelor'sMastersor PhD in Engineering or ChemistryRegulatory compliance experienceGMPISO 1348521 CFR 820NCRCAPAChange ControlMaster Batch RecordsMaster Packaging Records

Nice-to-Have Skills

Policy developmentProcedural documentationCMC knowledgeQuality systems optimizationrisk management

Tools & Platforms

ISO 1348521 CFR 820NCRCAPAChange ControlsMaster Batch RecordsMaster Packaging RecordsRisk Management PlanRisk AssessmentsMaster Packaging Records

Required Skills

Regulatory complianceGMPISO 1348521 CFR 820NCRCAPAChange ControlMaster Batch RecordsMaster Packaging RecordsRisk Management PlanRisk AssessmentsProcess controlData analysisCMC knowledgeSME

Hard Skills

ISO 1348521 CFR 820 Quality System RegulationsNCRCAPAChange ControlsMaster Batch RecordsMaster Packaging RecordsRisk Management PlanRisk Assessmentsdata analysisprocess controlregulatory requirementsSMEvalidationroot cause investigationdesign of experimentsstatistical methodsCMO collaboration

Soft Skills

leadershipmentoringtrainingcommunicationcross-functional collaborationproblem solving

Industry & Role

Industry Healthcare & Medical
Job Function Lead radiopharmaceutical process engineering and compliance initiatives
Role Subtype Process Engineer

Keywords for Your Resume

Principal Technical Operations EngineerRadiopharmaceuticalsISO 1348521 CFR 820NCRCAPAChange ControlMaster Batch RecordsMaster Packaging RecordsSMERegulatory complianceGMPProcess optimizationRisk managementQAQuality AssuranceRisk AssessmentsCMCradiopharmaceuticalsprocess optimization

Deal Breakers

Lack of degree in engineering or chemistry, No radiopharmaceutical manufacturing experience, Unwilling to work onsite in Indianapolis

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