AI Enabled Automation Architect

Vailexa • Indianapolis, IN

1d

About The Position

Vailexa is seeking an AI Enabled Automation Architect dedicated to Site Automation Engineering to support advanced pharmaceutical manufacturing initiatives. This role focuses on the continued development, maturation, and application of reusable phase libraries, equipment module abstractions, and digital knowledge structures that enable scalable and repeatable manufacturing automation. The role operates within a GxP and GMP regulated environment and works closely with site automation, process engineering, and execution teams to validate solutions using real batch records and real manufacturing use cases.

Requirements

• Experience with tech transfer, manufacturing automation, recipe design, control strategies, and batch execution workflows; specifically batch process experience, not continuous process control.
• Minimum 6 years of hands-on, batch-specific DeltaV configuration experience (not continuous), plus working knowledge of MES, data integration, and digital manufacturing architectures.
• Pharmaceutical or life sciences manufacturing experience; Small Molecule experience specifically preferred, with biologics, advanced therapies, or multi-modality experience considered a plus.
• Capability in data modeling, information architecture, knowledge representation, or related digital-knowledge disciplines.
• Experience bridging process knowledge and digital execution systems without over-reliance on custom application development.
• Hands-on experience with AI or machine learning tools in a regulated technical environment, with the aptitude and willingness to grow into more advanced AI-driven workflows (e.g. agentic architectures).

Nice To Haves

• AI-enabled analysis, decision support, or knowledge-system experience in regulated technical environments; particularly agentic architecture and coding experience (e.g. Claude Code, Codex).
• Change-management, training, and governance experience to help operationalize adoption across functions.
• Familiarity with data integrity principles (ALCOA+) and data governance frameworks.
• Experience with Kneat, ValGenesis, or similar electronic validation management systems.

Responsibilities

• Continued development, maturation, and application of reusable phase libraries, equipment module abstractions, and digital knowledge structures.
• Enable scalable and repeatable manufacturing automation.
• Operate within a GxP and GMP regulated environment.
• Work closely with site automation, process engineering, and execution teams to validate solutions using real batch records and real manufacturing use cases.
• Design modular, reusable technical frameworks rather than one-off implementations.
• Work iteratively using real process examples, user feedback, and rapid learning cycles.
• Engage cross-functionally with automation, process engineering, operations, PT&E, quality, and related stakeholder groups.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed