Process Validation Engineer

Senior Process EngineerOverview:Our client is seeking a Lead Process Engineer to guide and execute a large-scale fill/finish technology transfer. This role requires a senior, hands-on engineer who can walk into a site, assess existing documentation and processes, and lead the end-to-end tech transfer effort. The Lead Process Engineer will provide technical direction, validation strategy, and process control guidance, with dedicated document writing support provided. Drug product experience is highly preferred.Key Responsibilities:Lead large-scale fill/finish technology transfer activities from site intake through executionReview and assess existing process, batch, and tech transfer documentation; identify gaps and drive resolutionDefine and map the process control strategy in support of tech transfer and validationDrive batch execution activities, including engineering, PPQ, and validation batchesDevelop and own the validation strategy, providing technical content and direction to supporting teamsProvide technical guidance and source content to document writers for protocols, reports, and supporting documentationEngage directly with internal stakeholders and external clients to align on scope, timelines, and execution strategyServe as the technical lead and point of accountability for fill/finish tech transfer success