Process Engineer Support

Job Post Index 1F55F2-Sy##
Location Andover, MA
Description: Description
  • Seeking a Process Engineer to develop and execute commissioning protocols for upstream and downstream GMP process equipment.
  • Prepare this equipment for right first time qualification.
  • Assist automation and validation teams in running, testing, and troubleshooting this same equipment.
  • Assist with operations startup for new product engineering runs.
  • Provide engineering technical support related to the maintenance, installation, startup/commissioning, testing, and qualification of process equipment and process related systems within a biopharmaceutical manufacturing facility.
  • Provide process engineering support for the introduction of a new commercial product to the company site.
  • Cell culture, harvest, or purification process equipment design, development of startup documents, commissioning plans, validation/qualification documents, execution of commissioning plans, troubleshooting of equipment, executing qualification protocols, assisting maintenance, attending necessary meetings and maintaining specific training requirements.
  • Equipment maintenance history review, investigation and audit support, process/component improvement project support, and reliability engineering support.
Skills: Qualifications
  • Familiarity with good engineering practices
  • Familiarity with good manufacturing practices
  • Familiarity with commercial-scale drug substance purification processes
  • Knowledge of CIP/SIP functionality
  • Knowledge of PLC-based process control systems

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