Qualification & Validation Specialist

Eckert & Ziegler Radiopharma Inc•Wilmington, MA

1d•$60,000 - $100,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Radiopharmaceutical or FDA/NRC-regulated experience
Analytical equipment qualification experience
PMP or formal PM training
Sterile or aseptic manufacturing exposure

Responsibilities

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
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