Biochemical Engineer (Neurotoxin & Biologics Process Science)

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Biochemical Engineer will be an instrumental team member of the Neurotoxin & Biologics Process Sciences (NBPS) Department, based in Irvine, CA. The primary role of the Biochemical Engineer is to work within the biologics process development team to design, identify and implement new technologies, equipment and support and improve existing technologies to advance NBPS objectives. An ideal candidate would have the ability to work as an integral part of the process development teams and manufacturing teams as well as demonstrate a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of position.

The ideal candidate will support fermentation and purification process development groups, assist in designing and implementing biopharmaceutical processes and equipment (from laboratory to manufacturing scale), and support tech transfer and scale up activities. Additionally, the ideal candidate will work with scientist and associate scientists and evaluate and develop new technologies, lead and execute studies to examine process mapping/sequences, modifies systems to support process changes, recommends changes in operation protocols as applicable and develops ways to minimize and laboratory waste. Furthermore, the candidate will work to maximize lab space efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. The candidate will participate in gap analyses and risk assessments of operation of equipment and process and assist in mitigating the issues. Also, will prepare diagrams and designs, schematics for possible biologics process improvements.

The position will also provide technical leadership and develop or use existing tools and integrate process data to SCADA, create PI Historian process book, monitor and trouble shoot of processes and process equipment in dynamic environment. Additionally, the candidate will lead and provide recommendations on design drawings, will have strong understanding of blueprints that incorporate PFD, diagrams, mass balances and P&IDs, instrumentation and equipment control philosophies.
In addition, the position will support and provide routine process monitoring and troubleshooting of process equipment, and utilities, identify GMP suitable process raw material, perform data trending and statistical process analysis and identify and support process related operational excellence opportunities. Also, will collaborate and execute studies to develop a thorough understanding of operating parameters of unit operations for process improvements.
Other responsibilities include but not limited to - develop and improve documentation including SOPs, batch logs, and other technical documentation to drive continuous improvement and provides training on updated documents as needed. Also, will develop and maintain process specifications, P&IDs, PFDs, and other key technical documents, provide technical expertise for the commissioning and decommissioning of process equipment and associated utilities through teams composed of cross functional SMEs.

Furthermore, the position requires the individual to work with regulated 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 including health screening and background checks. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

The Biochemical Engineer in this position is expected to have strong knowledge of Upstream and Downstream processes, and related equipment; proven tech transfer skills from bench to manufacturing scale, and process deviations assessment that may affect quality attributes of biological drug substance. In addition, Strong capability in scientific/engineering/laboratory analysis, design and execution of the studies by applying quality by design (QbD), scale up and scale down model qualifications, troubleshooting and ability to apply sophisticated problem resolution abilities.
Additionally -
• Build strong relationships with the vendors for process equipment and assist in building additional lab capacity to deliver business objectives
• Strong knowledge of biologics manufacturing process equipment and supporting utility systems
• Perform process or equipment analysis and trend process or equipment performance.
• Work with vendor(s) to develop manufacturing equipment like single-use disposable rigid fermenter based on user-requirements for neurotoxin process development.
• Perform statistical analysis including design of experiments (DOEs) as appropriate.
• Author and review technical documentation, operation SOPs, risk assessment, technical reports and summary reports.

Qualifications

• B.S. degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & 2+ years of relevant experience or M.S. degree with 1+ year of experience.
• Hands-on experience in the operation of single use and stainless steel fermenter
• Experience desired in the following areas: historian/data collection systems and data analysis and reporting applications such as PI Historian, PI Process Book, Excel, JMP
• Experience with process engineering and implementation of new process technology for fermentation and primary recovery processes.
• Ability to think critically, analytically and have demonstrated troubleshooting and problem solving skills
• Experience scoping, developing and implementing capital projects

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.