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.
Recruiter Contact:
Name: Uzma Kousar Mohammed
Email:
uzma.kousar@intellectt.com
Phone: 732-993-4997INTELLECTT INCEqual Employment Opportunity:
Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.
Benefits: Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:
Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
Retirement Benefits: A 401(k)retirement savings plan is available. No employer matching or other employer contributions are provided.
Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.