Teams at ISPV Inc.

Support and own manufacturing process change controls, lead deviation and root cause investigations, design and execute process/challenge tests, support CAPA/BOM/MBR activities, enable campaign readiness, create training/materials, and drive process improvement and documentation in a regulated bioprocessing manufacturing environment.

Leads commissioning and qualification strategy and execution for regulated pharmaceutical systems. Responsibilities include risk assessments, FAT/SAT, IQ/OQ/PQ protocols, characterization, GMP-compliant documentation, change control, deviations, CAPA, data integrity, validation reports, and cross-functional coordination with engineering, quality, manufacturing, supply chain, vendors, and contractors. Provides technical guidance and mentorship to junior engineers.

Manage manufacturing documentation in Veeva Vault or similar platforms, author technical documents, own change control activities, coordinate projects, and use Smartsheet or comparable project-management tools. Qualifications include advanced education or equivalent manufacturing operations experience, ranging from a doctorate to high school/GED with ten years of experience.