LEAD AUTOMATION ENGINEER (475)

Réalta Technologies; De Soto (KS); On-site; USD 120,000 - 180,000; Full time

Job summary

Réalta Technologies in Kansas seeks a Lead Automation Engineer to serve as the project lead for an EMS rollout at a life sciences manufacturing facility. You will guide the SI, review control-system designs, and ensure compliance with GxP, CSV, and 21 CFR Part 11 requirements.

You will oversee Ignition HMI and PlantPAx configurations, drive standardization across sites, and mentor site automation staff while coordinating FAT/SAT and commissioning activities on-site in De Soto, KS.

Qualifications

• Bachelor's degree in Electrical, Controls, Chemical, or a related Engineering discipline.
• Significant automation engineering experience on capital projects within regulated life sciences manufacturing.
• Hands-on experience with the Ignition SCADA/HMI platform, including high-performance HMI/graphics design.
• Strong Allen Bradley PLC programming experience, including development and standardization of AOIs.
• Experience with Rockwell PlantPAx DCS architecture and configuration.
• Direct experience with Environmental Monitoring Systems (EMS) in GMP facilities.
• Demonstrated experience managing System Integrators on capital automation projects.

Responsibilities

• Act as client-side technical authority for the EMS implementation, ensuring design meets process, facility, and GxP requirements.
• Review and approve SI deliverables, including specifications, Ignition screens, and PLC/PlantPAx code.
• Oversee development of high-performance HMI screens and standardization of AOIs for reuse.
• Manage the SI relationship end-to-end from scope to FAT/SAT and on-site deployment.
• Coordinate FAT/SAT, IQ/OQ/PQ, and drive issue resolution to closure.
• Partner with global teams to convert Kansas implementation into a reusable template for other sites.
• Ensure SDLC execution under GAMP 5 with full change control and traceability.
• Validate EMS configuration against cGMP, 21 CFR Part 11, and data integrity requirements.

Job description

Réalta Technologies is searching for a Lead Automation Engineer to serve as our client's technical and project leader for a capital project delivering an Environmental Monitoring System (EMS) at a life sciences manufacturing facility in Kansas. The EMS solution is built on an Ignition high-performance HMI layer integrated with an Allen Bradley control platform (PlantPAx), monitoring critical environmental parameters across drug substance and drug product manufacturing areas.

This individual will provide hands‑on technical direction, manage the System Integrator (SI) responsible for designing, developing, and deploying the solution on site, and partner with global engineering teams to convert the Kansas implementation into a standardized template for deployment at other sites within the network.

Job Responsibilities

• Act as the client-side technical authority for the EMS implementation, ensuring the design meets process, facility, and GxP requirements.
• Review and approve SI deliverables, including functional/design specifications, Ignition HMI screens, and Allen Bradley PLC/PlantPAx configuration.
• Ensure Ignition HMI screens are developed to high-performance HMI standards (e.g., ISA-101) for effective operator interaction and alarm management.
• Oversee the development and standardization of Allen Bradley Add‑On Instructions (AOIs) to ensure consistency, reusability, and long-term maintainability.
• Oversee all vendor design work and PLC programming, including Ignition application development and Allen Bradley/PlantPAx code, ensuring adherence to site and global standards.
• Conduct formal code reviews of vendor-developed PLC logic, AOIs, and HMI applications prior to FAT/SAT, identifying and driving resolution of design, quality, and standards gaps.
• Manage the SI relationship end-to-end — scope, schedule, budget, and quality of deliverables — through design, development, factory acceptance testing (FAT), and on‑site deployment/commissioning (SAT).
• Hold the SI accountable to project milestones, technical specifications, and compliance requirements.
• Coordinate FAT/SAT execution and IQ/OQ/PQ support activities, and drive punch‑list and issue resolution to closure.
• Serve as the primary escalation point for technical issues between the SI, plant operations, engineering, and quality organizations.
• Partner with global automation and engineering teams to convert the Kansas EMS implementation into a reusable, standardized template for deployment at other sites.
• Define and document standards for Ignition architecture, tag/naming conventions, AOI libraries, alarm philosophy, and EMS configuration that can be replicated globally.
• Capture lessons learned and best practices, and support knowledge transfer to other regional and global project teams.
• Represent the site's implementation experience in global automation governance and standards forums.
• Own SDLC execution for the project in accordance with GAMP 5, covering URS, functional/design specifications, code review, and testing (FAT/SAT/IQ/OQ/PQ) — with full change control and traceability.
• Partner directly with Quality to align SDLC deliverables, code review records, and testing documentation with GAMP 5 and site computer system validation (CSV) requirements.
• Ensure the EMS solution meets cGMP, 21 CFR Part 11, and data integrity (ALCOA+) requirements applicable to environmental monitoring in drug substance and drug product areas.
• Support validation deliverables and coordinate with Quality/Validation teams on protocol execution, deviations, and CAPAs.
• Work closely with Process, Facilities, EHS, Quality, and Operations to align the EMS solution with facility monitoring requirements (temperature, humidity, differential pressure, particulate counts, and similar parameters).
• Support startup, commissioning, and operational readiness activities on site in Kansas.
• Provide technical mentorship to site automation and controls staff.

Job Requirements

• Bachelor's degree in Electrical, Controls, Chemical, or a related Engineering discipline, or equivalent professional experience.
• Significant automation engineering experience on capital projects within regulated life sciences (pharmaceutical/biotech) manufacturing environments.
• Hands‑on experience with the Ignition SCADA/HMI platform, including high-performance HMI/graphics design.
• Strong Allen Bradley PLC programming experience, including development and standardization of Add‑On Instructions (AOIs).
• Experience with Rockwell PlantPAx DCS architecture and configuration.
• Direct experience with Environmental Monitoring Systems (EMS) in GMP-regulated facilities.
• Demonstrated experience managing System Integrators on capital automation projects, including scope, schedule, deliverable quality, and FAT/SAT.
• Experience across both drug substance (API/bulk) and drug product (fill‑finish/packaging) manufacturing environments.
• Solid working knowledge of SDLC methodology under GAMP 5, computer system validation (CSV/CSA), and 21 CFR Part 11/data integrity requirements — including hands‑on experience conducting code reviews within a validated SDLC framework.

Other

• This is a site based role located at our client's site, an active pharmaceutical/life sciences manufacturing and construction environment in De Soto, KS.
• We are unable to provide Visa sponsorship for this position, so all applicants must have the correct legal work authorization to work in the United States.