Engineering - Assistant Process Engineer

Onsite Biopharmaceutical Process Specialist

Assignment is for routine business hours (i.e. 8am-4pm, 9am-5pm) Monday through Friday. Non-routine work may include on-call and onsite presence during night and weekends as part of quarterly rotation.

Work independently to assist in investigation of process deviations, data trending, change controls and other documentation. Perform manual or automated process performance data extraction, reporting and analysis. Support in the execution of protocols including scheduling, communication, and coordination of sample delivery and data collection. Coordinate activities between Manufacturing Technology, Manufacturing operating groups, Supply Chain, and QA/QC to meet project timelines. Achieve high customer satisfaction through effective communication of both technical and non-technical topics with all levels of the organization both verbally and in writing.

• Required BS degree in science or engineering related to biopharmaceutical process technology with a minimum of 1-2 years of biopharmaceutical industry experience.
• Experience with electronic database systems and statistical analytical packages is highly desirable.
• Excellent verbal & written communications skills.
• Interpersonal / facilitation skills necessary to interface with and influence all levels of the organization.
• Broad knowledge of biopharmaceutical facility design and manufacturing operations is highly desirable.
• Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is desirable.