Lead Automation Engineer (475)

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.