Process Development Engineer

5 hours ago

Thousand Oaks, United States Aditi Consulting Full time

Title: Process Development Engineer

Location: Thousand Oaks, CA

Duration: 12+ Months Contract

Job Description:

Seeking a Process Development Engineer to join the Drug Substance Technology Engineering team. Providing process engineering support for human therapeutic products in clinical development through commercial production, our mission is to translate developmental processes to commercial reality for patients through scientific expertise and engineering innovation

Specifically looking for upstream experience**

Strong communication - must be comfortable speaking to a group of 20+ manufacturing associates in presentation (data reviews/etc.)

GMP experience highly preferred (Looking for GMP background/ someone who has dealt with FDA/ inspectors/ auditors)

Under guidance of senior staff, the Engineer performs the following:

- Transfer upstream (cell culture & harvest) drug substance processes and facilitates process improvements from the laboratory into the manufacturing facility

- Provide technical support for successful scale-up, transfer of process technology, and for clinical and/or commercial manufacturing operations

- Offer process validation support for late stage commercial processes

- Provide routine process monitoring and troubleshooting

- Execute data trending and statistical process analysis

- Support technical direction for process related deviations, CAPAs and change controls

- Identify and support process related operational excellence opportunities

- Represent process development and collaborate with other functions such as Manufacturing, Quality, Engineering and Regulatory

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