Senior Principal Engineer, Factory of the Future
AbbVie
Summary
The Senior Principal Engineer, Factory of the Future, is the technical authority for designing next-generation AbbVie factories and manufacturing operations that integrate Industry 4.0/5.0, robotics, automation, and AI technologies. The role leads concept-through-detailed design and technology selection across biotechnology, aseptic fill/finish, packaging, medical device, and chemical production, setting the global reference designs, standards, and business cases for new facilities and major site transformations.
Job description
Factory Design and Technology Strategy
- Lead Factory of the Future elements of conceptual and basic design of new factories and major expansions, integrating process, facility, automation, material and personnel flow, and digital architecture across biologics/biotech, aseptic and sterile manufacturing, packaging and device assembly, and chemical production.
- Define and maintain the Factory of the Future technology roadmap and reference architectures covering robotics, isolators/RABS and closed-system processing, autonomous material handling (AMRs/AGVs), vision inspection, continuous and modular manufacturing, and AI-enabled operations.
- Embed human-centric, sustainable, and resilient design principles (ergonomics, operator-robot collaboration, energy and waste reduction) into factory concepts.
Automation, Robotics, and AI
- Specify and drive adoption of advanced automation and robotics for high-risk and repetitive operations (e.g., aseptic filling and set-up, sampling, inspection, packaging, warehouse and logistics), including contamination-control and GMP considerations.
- Partner with BTS and Operations AI to design the OT/IT stack: MES/MOM, process control, historians, shopfloor integration layer, digital twins and simulation, predictive quality and maintenance, advanced scheduling, and GenAI/agentic AI use cases, with cybersecurity by design.
Delivery and Technical Leadership
- Develop technology evaluations, pilots, proofs of concept, and business cases (capex/opex, throughput, OEE, yield, labor, quality) and transition proven solutions into standard designs and capital projects.
- Ensure designs meet cGMP, FDA/EMA Annex 1 and Annex 11/Part 11, data integrity, medical device (e.g., 21 CFR 820/ISO 13485), and EHS requirements; support commissioning, qualification, and validation strategies using risk-based approaches (CSA, ASTM E2500).
- Serve as a recognized subject matter expert and mentor for engineers across Global Engineering, sites, and external partners; review designs and provide technical governance for major projects.
- Engage equipment OEMs, automation integrators, technology startups, A&E firms, and industry groups (e.g., ISPE) to benchmark best practices and shape capabilities.
Requirements
- Bachelor's degree in Engineering (Chemical, Mechanical, Biomedical, Electrical, Automation, Industrial, or related) required
- Master's or PhD preferred
- Minimum of 10 years of experience in pharmaceutical, biotechnology, or medical device manufacturing engineering
- 5+ years in greenfield/brownfield facility design or technical leadership of capital projects
- Deep expertise in aseptic and sterile manufacturing (e.g., fill/finish, isolators/RABS, lyophilization) and/or biologics drug substance
- Working experience in packaging, device assembly, or chemical/API production is highly desirable
- Demonstrated experience implementing Industry 4.0/5.0 technologies: robotics, advanced automation (PLC/DCS/SCADA), MES/MOM, IIoT, vision systems, digital twins, and AI/ML in a GMP environment
- Strong knowledge of cGMP, Annex 1, data integrity, computer system validation/assurance, and equipment qualification requirements
- Proven ability to develop conceptual designs, URS, technology assessments, and business cases and to lead cross-functional design teams through to execution
- Working understanding of OT/IT cybersecurity, data architecture, and integration standards (e.g., ISA-95, OPC UA, ISA/IEC 62443)
- Track record of technical innovation, including piloting novel technologies and scaling them across sites or product platforms
- Exceptional communication and influencing skills, with the ability to engage senior leaders, site teams, and external partners in a global matrix
- Professional certifications (PE, PMP, ISPE CPIP, Six Sigma) and a record of publications, patents, or industry presentations are a plus
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Long-term incentive programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.