Validation Engineer

Validation Engineer I supports GMP Radiopharmaceutical facility operations in Indianapolis, drafting and executing CQV documents and protocols for office, warehouse, development, QC, sterility/microbiology, and GMP production areas; develops CQV strategies, collaborates with consultants, provides validation and engineering support to improve processes, and participates in CAPA, deviation investigations, Health Authority inspections, and continuous improvement projects. Responsibilities include commissioning/validation of a 60,000 sq. ft. facility, drafting GMP documents (SOPs, protocols, deviations, CAPAs, change controls, reports), and maintaining KPIs while supporting day-to-day GMP operations and facility expansion efforts.