Employment Type: Full-Time
OverviewThe 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.Responsibilities* Prepares GMP and proprietary documentation (ie. batch/cleaning records, equipment qualification, campaign reports, etc.) for the Pilot Plant and Kilo Lab.* Prepares QA documentation such as SOPs and TWIs to ensure cGMP compliance of processes and associated equipment in the Pilot Plant and Kilo Lab.* Evaluates current prcoedures and equipment in the Pilot Plant and Kilo Lab for continuous improvement.* Interacts with Quality Control, Quality Assurance, Materials Management, Facilities, Process R&D, EH&S, and Purchasing in an effective manner to optimize and execute GMP and non-GMP manufacturing campaigns.* Interaction with vendors for Pilot Plant and Kilo Lab equipment as needed for purchasing new equipment, planning maintenance and calibration, etc.* Participates in the execution of chemical processes in the Pilot Plant and Kilo Lab. Assists in routine operations for cleaning, CIP, solution preparation, and charging.* Performs safety testing (DSC, RC-1, TSU, etc.), analyzes data to assess process safety, and prepares process safety reports for GMP and non-GMP projects.* Assists with structural characterization of solid materials for GMP and non-GMP projects (PXRD, polarizing microscope, etc.) as needed.* Assists process chemists with lab work as needed.* Additional duties as assigned.Qualifications* Bachelor's degree or higher in Chemical Engineering or a related discipline.* Previous handling of chemicals preferred.* 1-2 years of relevant experience preferred.* Must be able to use and maintain large-scale Pilot Plant equipment and portable Kilo Lab equipment, with sufficient training (provided) within 6-12 months of hire.* Must be able to understand pharmaceutical production and testing/quality management with sufficient training (provided) within 6-12 months of hire.* Must be able to learn and follow GMP regulations.* Must be organized and able to work on multiple projects.* Must be skilled with a computer (MS Office suite).* Ability to learn chemical processing and/or process safety.* Must be medically fit to wear a respirator, lift 50 pounds, and be comfortable working with, and around hazardous materials.