Process Control Systems Technical Lead – Ignition / Rockwell SME

Position Summary

Seeking an experienced Process Control Systems (PCS) Technical Lead to lead automation design, development, integration, testing, and qualification for a new vial-filling and freeze-drying facility.

The role requires strong hands-on expertise in Ignition SCADA, Sepasoft Batch, Rockwell ControlLogix, and PlantPAx, along with experience overseeing system integrators, reviewing code, and delivering compliant automation systems in regulated pharmaceutical environments.

Key Responsibilities:

• Lead PCS implementation for site-built drug product manufacturing systems, process equipment, and supporting utilities.

• Establish and enforce PLC, SCADA, and batch programming and configuration standards.

• Review system integrator designs and code, document findings, and verify corrective actions.

• Lead integration with OEM equipment, third-party PLCs, and supporting systems.

• Support historian configuration, reporting, SQL databases, and IT/OT network architecture.

• Oversee module and integration testing; lead FAT, SAT, and qualification activities, including IQ/OQ, and support PQ.

• Manage software versions, backups, and changes using project change-control procedures and Rockwell FactoryTalk AssetCentre.

• Author, review, and approve automation lifecycle and validation documentation.

Required Qualifications:

• Background in Engineering, Automation, Computer Engineering, or a related technical discipline.

• Minimum 10 years of industrial automation experience, including 5 years supporting pharmaceutical manufacturing automation projects.

• Demonstrated technical leadership on large-scale automation deployments in regulated pharmaceutical environments.

• Strong knowledge of drug product manufacturing operations, including vial filling, freeze-drying, process equipment, and utilities.

• Experience supervising programming work, conducting detailed code reviews, and enforcing development standards.

Required Technical Expertise:

• Ignition SCADA: Module configuration, application development, and custom scripting.

• Sepasoft Batch: ISA-88/ISA-95-based batch models, procedures, unit procedures, recipes, and track-and-trace functionality.

• Rockwell ControlLogix / PlantPAx: Ladder Logic, Sequential Function Charts (SFC), equipment phases, and extensive use of the PlantPAx process library.

• Systems Integration: SCADA-to-PLC and PLC-to-PLC interfaces, including OEM equipment integration.

• Data and Infrastructure: Data historization, reporting, SQL scripting, databases, and IT/OT network design.

• Software Management: FactoryTalk AssetCentre, version management, and controlled software changes.

Validation and Compliance:

Lead computerized system validation and maintain compliance with applicable USDA and GMP requirements, GAMP 5, GDP, ALCOA+, ISA-88, and ISA-95, along with project programming standards.

Documentation responsibilities include:

• Validation Plans and User Requirements Specifications (URS).

• Functional Specifications (FS) and Software/Hardware Design Specifications (SDS/HDS).

• Risk assessments and requirements traceability matrices.

• Module, integration, FAT/SAT, and IQ/OQ/PQ test protocols.

• Validation Summary Reports.

Key Skills: Ignition SCADA, Sepasoft Batch, Rockwell ControlLogix, PlantPAx, PLC/SCADA Integration, ISA-88/ISA-95, System Integrator Code Reviews, FAT/SAT, IQ/OQ/PQ, Computerized System Validation (CSV), GMP/GAMP 5 Compliance, SQL/Historian, and FactoryTalk AssetCentre