- Workplace
- Onsite
- Type
- Full-time
- Department
- Engineering
- Seniority
- Lead
- Education
- Bachelor
- Visa
- Not sponsored
- Source
- RecruiterFlow
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
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Act as the client-side technical authority for the EMS implementation, ensuring the design meets process, facility, and GxP requirements.
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Review and approve SI deliverables, including functional/design specifications, Ignition HMI screens, and Allen Bradley PLC/PlantPAx configuration.
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Ensure Ignition HMI screens are developed to high-performance HMI standards (e.g., ISA-101) for effective operator interaction and alarm management.
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Oversee the development and standardization of Allen Bradley Add-On Instructions (AOIs) to ensure consistency, reusability, and long-term maintainability.
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Oversee all vendor design work and PLC programming, including Ignition application development and Allen Bradley/PlantPAx code, ensuring adherence to site and global standards.
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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.
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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).
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Hold the SI accountable to project milestones, technical specifications, and compliance requirements.
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Coordinate FAT/SAT execution and IQ/OQ/PQ support activities, and drive punch-list and issue resolution to closure.
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Serve as the primary escalation point for technical issues between the SI, plant operations, engineering, and quality organizations.
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Partner with global automation and engineering teams to convert the Kansas EMS implementation into a reusable, standardized template for deployment at other sites.
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Define and document standards for Ignition architecture, tag/naming conventions, AOI libraries, alarm philosophy, and EMS configuration that can be replicated globally.
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Capture lessons learned and best practices, and support knowledge transfer to other regional and global project teams.
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Represent the site's implementation experience in global automation governance and standards forums.
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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.
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Partner directly with Quality to align SDLC deliverables, code review records, and testing documentation with GAMP 5 and site computer system validation (CSV) requirements.
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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.
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Support validation deliverables and coordinate with Quality/Validation teams on protocol execution, deviations, and CAPAs.
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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).
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Support startup, commissioning, and operational readiness activities on site in Kansas.
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Provide technical mentorship to site automation and controls staff.
Job Requirements
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Bachelor's degree in Electrical, Controls, Chemical, or a related Engineering discipline, or equivalent professional experience.
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Significant automation engineering experience on capital projects within regulated life sciences (pharmaceutical/biotech) manufacturing environments.
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Hands-on experience with the Ignition SCADA/HMI platform, including high-performance HMI/graphics design.
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Strong Allen Bradley PLC programming experience, including development and standardization of Add-On Instructions (AOIs).
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Experience with Rockwell PlantPAx DCS architecture and configuration.
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Direct experience with Environmental Monitoring Systems (EMS) in GMP-regulated facilities.
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Demonstrated experience managing System Integrators on capital automation projects, including scope, schedule, deliverable quality, and FAT/SAT.
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Experience across both drug substance (API/bulk) and drug product (fill-finish/packaging) manufacturing environments.
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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.
Skills
GMPPLCSCADACompliance
