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.
Familiarity with good engineering practices
Familiarity with good manufacturing practices
Familiarity with commercial-scale drug substance purification processes