Job Title: Process Control Systems Technical Lead Ignition / Rockwell SME
Company: Intellectt Inc
Location: De Soto, Kansas
Project: Greenfield Animal Health Drug Product Manufacturing Facility
Experience: 10+ years in industrial automation, including 5+ years in pharmaceutical manufacturing automation
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.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com