The Process Engineer prepares GMP documentation such as batch/cleaning records, equipment qualification protocols, campaign reports, etc. for the Pilot Plant and Kilo Lab. Prepares QA documents such as SOPs/TWIs to ensure cGMP compliance. Evaluates and improves current procedures and equipment in the Pilot Plant. Interacts with QA, QC, Process R&D, Materials Management, EH&S, Facilities, and Purchasing to optimize and execute manufacturing campaigns. Assists with the execution of GMP and non-GMP production in the Pilot Plant and Kilo Lab. Performs safety testing (DSC, RC-1, TSU, etc.) and other tests to collect and analyze data for project support.