Qualification & Validation Specialist

Qualification & Validation Specialist Eckert & Ziegler Radiopharma Inc - 3.0 Wilmington, MA Job Details Full-time $60,000 - $100,000 a year 3 hours ago Qualifications Project reporting Pharmaceutical regulatory compliance GMP Scientific protocols Technical writing Progress tracking (project management tasks) Engineering validation Full Job Description Validation Specialist & Project Manager Drive Validation & Expansion in Nuclear Medicine On-site - Wilmington, MA Local candidates only. Relocation not provided. Eckert & Ziegler Radiopharma, Inc. (EZRI) is expanding its U.S. radiopharmaceutical manufacturing operations, including new production capabilities supporting targeted cancer therapies. We are seeking a hands-on Validation Specialist & Project Manager to execute equipment qualification and validation activities while owning the detailed project management of the site expansion within a regulated cGMP and NRC-licensed environment.

This is a dual-role position:

you will write and execute validation protocols while driving the cross-functional expansion program to completion. What You'll Do Validation & Qualification Author and execute

DQ/IQ/OQ/PQ

protocols Support FAT/SAT with vendors and sister company teams Perform equipment and process risk assessments Ensure compliance with FDA cGMP (21 CFR 210/211) and NRC requirements Support method validation and process validation documentation Maintain inspection-ready validation records Expansion Project Management Own and maintain the expansion Gantt (tasks, dependencies, milestones) Maintain a live status dashboard and risk register Drive cross-functional teams (Quality, Operations, Radiation Safety, Engineering) Run project meetings and enforce accountability Provide concise status reporting to site leadership Oversee external contractor qualification deliverables Qualifications Required 3-7 years of pharmaceutical/biopharmaceutical validation experience Direct experience executing

DQ/IQ/OQ/PQ

Strong knowledge of FDA cGMP regulations Experience writing protocols, reports, SOPs, and GMP documentation Demonstrated project management capability (Gantt ownership, milestone tracking) Strong written communication and documentation skills Preferred Radiopharmaceutical or FDA/NRC-regulated experience Analytical equipment qualification experience PMP or formal PM training Sterile or aseptic manufacturing exposure Work Structure Full-Time Role On-site presence required (hands-on qualification execution) Reports to the Director of Quality High visibility role driving a critical manufacturing expansion Why EZRI? Direct impact on cutting-edge nuclear medicine manufacturing Own both execution and program delivery Collaborative, mission-driven environment Competitive hourly compensation