3823 Associate Engineer I (cell culture)

Description:
The production facility makes pharmaceutical proteins from mammalian cells using large-scale production techniques.
The MSCC group provides technical support and stewardship for Cell culture and harvest process, which focuses on mammalian cell culture growth and production of drug substance.
We play a key role during all aspects of the product lifecycle, from transfer into the manufacturing facility through commercialization and ongoing monitoring of operations, to ensure consistent process performance.

Responsibilities/activities may include, but not limited to:
Supporting cell culture tech transfer and commercial process monitoring.
Reviewing of manufacturing specifications against process descriptions and characterization reports to ensure successful engineering and qualification runs at large scale.
Responsible for authoring technical document.
Process monitoring activities include compilation and analysis of cell culture data to ensure consistent performance of commercial production.
The position may involve some work during non-business hours.

Skills Preferred:
Working experience in cGMP biopharmaceutical production setting (process development and/or manufacturing technical support).
Knowledge of Process Validation approaches, industry practice, and applicable regulations and guidance and MP documentation requirements.
Knowledge with statistical methods (e.g. Design of experiments, and multivariate data analysis techniques).
Knowledge with OSisoft, Inc., PI Server and client tools, Oracle server and client tools, Microsoft Visual Studio, Visual Basic, SQL, SAS JMP and associated scripting language.

Education
To be eligible for this position, contractor must have completed BS or higher degree, and strong technical writing and oral communication skills.

PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.