Design Verification Lead
Boston Associate Software Systems
FULL_TIME
Remote · US
Lebanon, IN, United States, IN, US
Posted: 2026-05-11
Until: 2026-07-10
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Job Description
Ensure alignment with GMP , ICH Q8 Q11 , FDA , EMA , and ISPE Baseline Guide expectations for biologics manufacturing. Lead crossfunctional teams to translate process needs into User Requirements Specifications (URS) . Ensure all requirements are testable, traceable, and technically feasible . Develop, implement, and maintain the Design Verification (DV) framework for facility, equipment, automation, and process changes. Drug Substance Manufacturing