3 Key Consulting is hiring an Associate Engineer for Drug Product Manufacturing Data Analysis for a consulting engagement with a leading global biopharmaceutical company. The role involves implementing digital systems for data management, conducting data analysis, and supporting investigations related to process monitoring.
Responsibilities:
- Implementation/enhancement of digital systems and automated analysis/visualization tools (Spotfire) that are utilized for streamlining data management and data monitoring
- Data extraction, verification, analysis, and technical reports for process monitoring
- Supporting investigations of adverse signals identified through process data monitoring
- Integration of new products and processes to data monitoring business process and quality management system
- Support for other ad hoc studies and projects as applicable (e.g. technology transfers of processes to new sites)
Requirements:
- Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
- Some industry experience through internship or research projects
- Educational background in engineering, data sciences, biology, chemistry, or related discipline
- Drug product experience in Fill finish or inspection
- Experience with Excel, statistical process control, Spotfire or Tableau
- Manufacturing experience; strongly preferable for this experience to be in drug product/pharmaceutical field
- Experience with data entry, verification, analysis, and/or data management IS systems
- Located near Thousand Oaks or Cambridge sites for occasional onsite work