Purpose:
The Global Process Support Engineer (Biologic) will support the AbbVie Technical Operations Functions and the AbbVie Technical Centers worldwide. This position will be responsible for applying advanced scientific knowledge, engineering knowledge, mathematics, and ingenuity to complete complex assignments related to biologic capital projects and process troubleshooting. The selected candidate will contribute to the development of new principles, concepts, innovative ideas, and is expected to lead change from an engineering perspective. Will also be responsible for solving operating issues and providing technical support to cross-functional teams within the Biologic sites.
Responsibilities:
- Identifies biologics equipment for $multi-million capital projects working across engineering disciplines, including specifying and purchasing equipment.
- Serves as organization spokesperson on advanced projects and/or programs related to pharmaceutical biotechnology including equipment selection. Presents results of projects both internally and externally.
- Acts as advisor to management and operating sites on applications of new advanced processing equipment and participates in project planning, process update
- Act as a core technical contributor on cross-functional teams, providing subject-matter expertise to drive alignment, problem-solving, and execution of complex initiatives.
- Responsible for timely project completion and adherence to project timelines.
- May act as lead engineer, project leader, or project contributor.
- Ensures quality and effectiveness of biotechnology solutions as part of major projects through sound design, early risk assessments, and implementation strategies. Has full awareness of the potential consequences (defects and failure modes) of design changes to established processes.
Other responsibilities include:
- Evaluate novel technologies to identify opportunities for process optimization and operational improvement
- Evaluates and integrate relevant engineering advances for improving or solving problems. Understands the business implications of assigned products and processes and identify engineering solutions compatible with business needs.
- Provides technical direction and feedback to others.
- Responsible for compliance with applicable corporate and local policies and procedures.
Qualifications:
- Bachelors Degree in Chemical or Mechanical Engineering or related field in Chemical Engineering or related field with 6 to 8 years of engineering experience
- Masters degree or higher preferred
- 10+ years of experience preferred
- Experience in pharmaceutical biotechnology process design, equipment selection, and operation in one of the following areas:
- Cell Culture and Upstream Processing - Cell Culture, Seed Train, Bioreactors
- Downstream Processing - Harvest, Primary Recovery, Centrifugation, Chromatography, Filtration
- Preferred experience in single-use technology
- Experience in manufacturing Monoclonal Antibodies (mAbs)
- Preferred experience in Cell and Gene Therapy
- Knows the process equipment market and biotechnology and has contacts with leading suppliers
- Has worked as an equipment SME or process engineer in large capital projects
- Has strong technical knowledge of equipment design and project lifecycle
- Demonstrated excellence in breadth and depth of knowledge within the pharmaceutical biotechnology discipline and is recognized as a subject matter expert
- Experience participating or leading FMEA, Risk Assessments, or investigations for biologics pharmaceutical processes
- Experience in corporate engineering group environment
- Processes a strong technical knowledge of cGMP processing and aseptic best practices
- Processes a strong technical knowledge and application of concepts, practices, and procedures including application of regulatory requirements.
- Processes a working technical knowledge of distributed control systems and electronic batch records
- Preferred experience with Emerson DeltaV
- Interacts well with diverse groups within engineering and science and technology groups. Maintains strong working relationships with internal and external collaborators and stakeholders
- Possesses interpersonal skills to negotiate and reconcile differences
- Has a good understanding of key literature beyond regulations (ISPE, ASME, ISO, USP)
