Qualification & Validation Specialist

Job Description

Job DescriptionValidation 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 DoValidation & 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