Technical Engineer

Job Description
The individual will provide scientific and technical support as an SME for process engineering and manufacturing technologies.
The role will collaborate with teams from Manufacturing, Quality, Compliance, S&
T, and R&
D functions to ensure a high degree of GMP compliance, manufacturing operations, data trending, process optimization, investigations, gap &
risk assessments, problem-solving, and knowledge transfer.
The individual will provide technical oversight for implementing manufacturing systems, including evaluation, procurement and implementation, design, GMP documentation, technical writing, validation activities, qualification, technology, and knowledge transfer.
Provide technical and scientific support, subject matter expertise on commercial and clinical manufacturing support, technology transfers, complex deviations, technical troubleshooting, CAPA design, process monitoring, change control, and optimization
Support gap assessments, risk assessments, qualification, and validation activities, ensuring the technology is optimally compatible with desired operational processes and GMP requirements.
Support investigations on process abnormalities as well as recommend corrective and preventative actions
Lead data analysis of process data statistics, data visualization, data mining, design of experiments, identifying process deviations, assessing product impact, and preparing technical reports while proposing solutions and improvements.
Manage cross-functional assignments, including the evaluation, procurement, and implementation of manufacturing systems and equipment, design, GMP documentation, technical writing, qualification, technology, and knowledge transfer.
Work safely and observe all general plant and department safety policies to help achieve environmental, health, and safety goals.
Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.E. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements.