Qualification and Validation/Project Manager Specialist

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.

• 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

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

• 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