Digital Plant Lead
Job
LVI Associates
[Unknown City], IN (In Person)
Full-Time
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Job Description
Program OverviewA global pharmaceutical manufacturer is developing a new multi‑billion‑dollar greenfield manufacturing campus. The program includes the construction of multiple standalone, highly flexible GMP clinical trial drug substance facilities, along with site infrastructure, utilities, administrative offices, laboratories, and warehousing.
The facilities will manufacture clinical trial drug substances supporting small molecules, biologics, and advanced therapeutic modalities. The overall program is currently in the detailed engineering design phase.
Automation Program OverviewThe Automation Program consists of multiple independent Automation Project Teams, each responsible for a specific facility and operating under the governance of a centralized Automation Program Office.
Each Automation Project Team includes:
Automation Project ManagerTechnical LeadAutomation Area LeadsDigital Plant EngineerThese teams define automation hardware and software requirements, standards, and best practices, and lead the engagement and oversight of system integrators responsible for detailed automation design, coding, testing, and deployment.
Purpose of the RoleThe Digital Plant Engineer is embedded within a Project Automation Team and is responsible for understanding manufacturing processes and ensuring that digital and data solutions align with:
Product processesFacility designRegulatory and compliance requirementsThe role spans process control, automation‑MES integration, historian delivery, PAT platform oversight, digital use‑case development, and data integrity compliance.
The Digital Plant Engineer collaborates closely with:
Automation Project TeamsProgram Technical leadershipProcess EngineeringProcess Technical TransferIT / Digital organizationsEnd users and site stakeholdersRole ResponsibilitiesBridge business, technology, and data architectures for the manufacturing facilityRepresent the automation function in digital plant forums and design discussionsContribute to the digital strategy and definition of digital plant use casesContribute to the development of the project data architectureLead data‑flow mapping activities across systems and platformsSupport delivery of site‑level data infrastructure (e.g., historians, log management platforms)Contribute to the overall automation philosophy for the programCommunicate progress, risks, and needs to the Automation Project ManagerProvide technical consulting as part of the Project Automation TeamInterface with cross‑functional disciplines to ensure project deliverables meet business and operational needsMaintain compliance with all required training and quality standardsRole RequirementsStrong background in automation and OT operations (DCS engineering, batch manufacturing)Proven ability to translate process and operational needs into digital requirementsExperience working across operations, process engineering, automation, and IT, effectively bridging functional silosBachelor's degree in Engineering (or equivalent experience)7+ years of experience in pharmaceutical API or bulk manufacturing environmentsPrevious experience delivering large‑scale automation projects in the pharmaceutical industryPrior hands‑on experience with batch DCS platforms (e.g., DeltaV Batch)Preferred experience with MES systemsPreferred experience with plant historian platforms (e.g., PI systems)Strong understanding of GMPs, regulatory expectations, and computer system validation (CSV)Exceptional teamwork and collaboration skillsExcellent verbal and written communication skills for both technical and non‑technical audiences
The facilities will manufacture clinical trial drug substances supporting small molecules, biologics, and advanced therapeutic modalities. The overall program is currently in the detailed engineering design phase.
Automation Program OverviewThe Automation Program consists of multiple independent Automation Project Teams, each responsible for a specific facility and operating under the governance of a centralized Automation Program Office.
Each Automation Project Team includes:
Automation Project ManagerTechnical LeadAutomation Area LeadsDigital Plant EngineerThese teams define automation hardware and software requirements, standards, and best practices, and lead the engagement and oversight of system integrators responsible for detailed automation design, coding, testing, and deployment.
Purpose of the RoleThe Digital Plant Engineer is embedded within a Project Automation Team and is responsible for understanding manufacturing processes and ensuring that digital and data solutions align with:
Product processesFacility designRegulatory and compliance requirementsThe role spans process control, automation‑MES integration, historian delivery, PAT platform oversight, digital use‑case development, and data integrity compliance.
The Digital Plant Engineer collaborates closely with:
Automation Project TeamsProgram Technical leadershipProcess EngineeringProcess Technical TransferIT / Digital organizationsEnd users and site stakeholdersRole ResponsibilitiesBridge business, technology, and data architectures for the manufacturing facilityRepresent the automation function in digital plant forums and design discussionsContribute to the digital strategy and definition of digital plant use casesContribute to the development of the project data architectureLead data‑flow mapping activities across systems and platformsSupport delivery of site‑level data infrastructure (e.g., historians, log management platforms)Contribute to the overall automation philosophy for the programCommunicate progress, risks, and needs to the Automation Project ManagerProvide technical consulting as part of the Project Automation TeamInterface with cross‑functional disciplines to ensure project deliverables meet business and operational needsMaintain compliance with all required training and quality standardsRole RequirementsStrong background in automation and OT operations (DCS engineering, batch manufacturing)Proven ability to translate process and operational needs into digital requirementsExperience working across operations, process engineering, automation, and IT, effectively bridging functional silosBachelor's degree in Engineering (or equivalent experience)7+ years of experience in pharmaceutical API or bulk manufacturing environmentsPrevious experience delivering large‑scale automation projects in the pharmaceutical industryPrior hands‑on experience with batch DCS platforms (e.g., DeltaV Batch)Preferred experience with MES systemsPreferred experience with plant historian platforms (e.g., PI systems)Strong understanding of GMPs, regulatory expectations, and computer system validation (CSV)Exceptional teamwork and collaboration skillsExcellent verbal and written communication skills for both technical and non‑technical audiences
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