The Scientist II (Process and Validation) is a technical expert that will independently investigate, identify, develop, and optimize new process improvements or methods to address critical project needs for the Small Volume Parenteral or Bulk Drug Substance Technical Center. Continuously seek to improve existing manufacturing or laboratory methods and processes. Read and adapt literature to accomplish assignments. Demonstrate mastery of broad range of technical process support, experimental techniques, and methods of data analysis.

• Independently design, execute and interpret critical experiments to answer scientific questions for manufacturing technical evaluation, new product introduction, or continuous process improvement initiatives. Understand the broad objectives of the project as well as their role in achieving those objectives, and modify experimental plan when required, to respond.
• Act as process SME for designated area of parenteral manufacturing for the technical center. Interprets problems and either creates or modifies design solutions. Reviews existing layouts and standards and creates a proposed design. Applies standard engineering principles and methodologies to interpret, draw conclusions and recommend solutions for problems considering a broad range of factors. Improves methods/designs/processes. Recognizes and implements innovations and cost reductions.
• Routinely read and apply relevant scientific literature. Impact projects mostly through lab and/or site activities where applicable.
• Contribute to writing and conceptual framework of technical protocols, reports, publications, and presentations. Conveys information effectively through verbal, written, and presentations to stakeholders and team members, both internal and external to AbbVie, using appropriate communication protocols. Identifies ways to increase customer satisfaction. Documents agreements and commitments and keeps direct customers informed throughout the project or initiative.
• Innovate and implement new experimental protocols. Plans and conducts small-sized assigned projects within engineering specialty requiring conventional types of plans, investigations, and/or equipment. Implements plans; initiates execution of own work plan; monitors executions for adherence to plan, e.g. documents work status and reports to management with appropriate frequency. Coordinates with technical support personnel to conduct prototype or experimental runs of products or processes
• Demonstrate a high level of proficiency in his/her field. Keep aware of the changing technical and competitive environment as it relates to the business and share with co-workers. Participates and/or assists other engineers in the design of products/processes/equipment/systems/ facilities by applying standard engineering theories, concepts, and techniques within the discipline. Investigates, conducts tests, gathers data, performs preliminary analysis, report findings, and prepares and communicates recommendations and respective action plans.
• Learn, understand, and master new experimental techniques, and act as a resource or mentor for others.
• Set and meet experimental timelines. Implements plans; initiates execution of own work plan; monitors executions for adherence to plan, e.g. documents work status and reports to management with appropriate frequency. Coordinates with technical support personnel to conduct prototype or experimental runs of products or processes.
• Effectively organize and present scientific plans and data.
• Responsible for compliance with applicable regulations and standards for Quality; Environment, Health, and Safety (EH&S) Global Policies; AbbVie Engineering Standards; and other governance areas as applicable. Identifies areas of risk with respect to compliance. Assists in development and revision of procedures and standards.

Qualifications

• Bachelor's degree in Science, preferably in Bio-Chemistry or Chemical Engineering with 6 years of experience in a related field; or Master's Degree in Science, preferably Microbiology, Biology, Chemistry Bio-Chemistry or Chemical Engineering with 4 years of experience in related field; or PhD in Science with 2 years of experience in a related field.
• The selected candidate must have experience in parenteral manufacturing, especially with experience in quality systems (being able to own or assess the impact for change plans/change control), and product transfer.
• Must have experience in Tech Transfer and Process Support for parenteral manufacturing.
• Must have the ability and experience to author technical protocols and reports
• Experience in areas of supplier/commodity changes or compounding/filling is preferable.
• Must demonstrate the ability to manage multiple priorities and comply with deadlines.
• Maintains their certifications as needed for assigned job tasks.
• Demonstrates strong analytical skills and logical thought processes.
• Ability to quickly gain knowledge, understanding, or skill and willingly absorb and comprehend AbbVie processes, policies, and methods. Possess good human relation skills in both implementing and coordinating efforts involved across several disciplines.
• Interacts well with diverse groups within engineering and maintains strong working relationship with internal and external collaborators.
• Listens to and understands others’ points of view and articulates tactfully and respectfully one’s own perspective orally, in writing, and in presentations.
• Ability to recognize risks versus the relative gains associated with actions.

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.