WuXi AppTec

Process Engineer

Job Locations US-CA-San Diego
Job ID
2020-6832

Overview

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.

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. 

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