Senior Automation Architect

Position Summary

The Senior Automation Architect is responsible for leading and managing automation projects that support manufacturing process improvements and new product introductions. This role partners closely with plant facilities teams to assess project feasibility, define scope, and drive initiatives from concept development through full production handoff. 

The Automation Architect will collaborate with external integrators to ensure solutions meet performance requirements, adhere to established timelines, and effectively support operational goals. The role requires strict adherence to internal systems, controls, standard work, and quality compliance.

The ideal candidate has strong experience in automation design concepts, manufacturing technologies, and industry best practices. They must demonstrate sound judgment, solid project management capabilities, and the ability to solve complex problems with creativity and autonomy. A high degree of innovation, ownership, and cross-functional leadership is expected.

What You'll Do As a Sr. Automation Architect

• Assess feasibility, technical requirements, and cost–benefit scenarios for automating existing or new manufacturing processes.
• Develop clear and complete User Requirement Specifications (URS) to guide integrators and internal stakeholders.
• Lead a cross-functional core team throughout the full project lifecycle—from concept, design, build, FAT/SAT, validation, and final production transfer.
• Act as the project manager responsible for planning, scheduling, risk management, budget control, and status reporting.
• Support process preparation and readiness activities, including layouts, tooling needs, utilities, capacity models, and equipment interface requirements.
• Evaluate automation designs and proposals, ensuring technical feasibility, design robustness, manufacturability, and alignment with project goals.
• Collaborate closely with automation integrators to ensure timely execution, efficient solutions, and alignment with specifications and standards.
• Support facilities teams with ROI calculations, financial modeling, and justification for capital expenditure approvals.
• Plan, coordinate, and lead Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT), ensuring that systems fully meet user, quality, and regulatory requirements.
• Ensure a safe working environment by following all safety practices, reporting hazards, and ensuring safe design principles are incorporated into automation equipment.
• Demonstrate commitment to patient safety and product quality by ensuring compliance with all applicable FDA regulations, international standards, Quality Systems, and internal policies.
• Promote a culture of quality and compliance across the project team and ensure all automation solutions meet validation and documentation requirements.
• Evaluate emerging technologies and automation opportunities that may provide competitive advantages, improve efficiency, or enable new products or processes.
• Provide technical leadership and consultation to internal teams and corporate groups regarding automation capabilities, equipment selection, and process improvements.
• Conduct due diligence for new automation platforms or product introductions, including risk assessments, manufacturability analysis, and alignment with long‑term automation strategy.
• Oversee equipment installation, commissioning, and troubleshooting to ensure smooth integration into production environments.
• Develop or support the development of standard work, documentation, and training materials for production, maintenance, and engineering teams.
• Track and report project performance metrics, including schedule, cost, risks, and issues, while driving timely resolution of technical challenges.

Education Degree

The Experience, Skills, and Abilities Needed

• Minimum fifteen (15) years of hands-on experience in automation engineering, with strong expertise in filling, capping, and related manufacturing processes.
• At least five (5) years of experience as a Project Manager, including project planning, reporting, risk management, and cross‑functional leader­ship.
• Demonstrated experience managing CAPEX projects, including scope development, budgeting, justification, and execution.
• Proven success working effectively across multi‑site operations, ensuring alignment, consistency, and knowledge sharing.
• Track record of leading complex, high‑impact automation projects with cross-functional engineering, operations, quality, and supplier teams.
• Experience collaborating with external automation integrators, equipment OEMs, and technical vendors.
• Strong background in manufacturing equipment commissioning, FAT/SAT, troubleshooting, and production transfer.
• Familiarity with regulated manufacturing environments, including adherence to quality systems, validation processes, and documentation requirements (e.g., FDA/GxP, ISO).
• Experience developing or refining URS, validation plans, and technical documentation for automated systems.
• Demonstrated ability to evaluate and adopt new technologies, robotics, vision systems, material handling systems, and digital manufacturing tools.