Senior Principal Engineer, Factory of the Future at AbbVie · LumiJobs

Responsibilities

Future-state factory design: 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.
Technology roadmap: 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.
Industry 5.0 principles: Embed human-centric, sustainable, and resilient design principles (ergonomics, operator-robot collaboration, energy and waste reduction) into factory concepts.
Automation and robotics: 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.
Digital and AI integration: 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.
Business case and risk management: 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.
Compliance and quality: 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).
Technical authority and mentoring: 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.
External ecosystem: Engage equipment OEMs, automation integrators, technology startups, A&E firms, and industry groups (e.g., ISPE) to benchmark best practices and shape capabilities.
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, including 5+ years in greenfield/brownfield facility design or technical leadership of capital projects.

Qualification

Strong knowledge of cGMPTrack record of technical innovationProfessional certifications (PE

Required

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.
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our long-term incentive programs.

Senior Principal Engineer, Factory of the Future

Responsibilities

Qualification

Required

Benefits

Company

AbbVie

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