Automation & Controls Engineer- Aseptic & Packing Systems

About the Company

Nivagen is a global company dedicated to enhancing lives by developing and providing cost-effective generic prescription drugs and over-the-counter products for the North American market. For over a decade, we've remained steadfast in our commitment to the core values of excellence, integrity, and respect for people. Our team of professionals collaborates tirelessly to pioneer advancements in manufacturing, distribution, and quality control, ensuring a holistic approach to healthcare.

Through vertical integration of the pharmaceutical supply chain, cutting-edge technology, and unwavering dedication to excellence, we continually strive to redefine medication accessibility and affordability. We prioritize our employees' well-being by offering competitive pay, comprehensive benefits, and robust training and development opportunities. By investing in our workforce and fostering a culture of growth and support, we empower our team to drive innovation and make a positive impact in the healthcare industry.

At Nivagen, our mission is clear: to make a meaningful difference in people's lives by delivering high-quality, affordable medications while upholding the highest standards of integrity and excellence.

Nivagen Pharmaceuticals

3900 Duckhorn Dr, Sacramento, CA 95834.

The Automation & Controls Engineer – Aseptic & Packaging Systems is responsible for supporting, maintaining, troubleshooting, and improving automation and control systems used in a cGMP pharmaceutical manufacturing environment. This role supports aseptic processing, sterile filling, inspection, packaging, utilities, and facility automation systems.

The Automation & Controls Engineer provides technical ownership and support for systems such as PLCs, HMIs, SCADA, manufacturing equipment controls, vision systems, serialization systems, data historians, robotics, motion control, building automation interfaces, and equipment network infrastructure.

This position works cross-functionally with Manufacturing, Maintenance, Quality Assurance, Validation, Engineering, IT/OT, Facilities, Packaging, and Equipment Vendors to ensure automated systems operate safely, reliably, and in compliance with GMP, data integrity, validation, computerized system, and change control requirements.

• Provide daily technical support for automation and control systems used in pharmaceutical manufacturing, packaging, inspection, and facility operations.
• Troubleshoot PLC, HMI, SCADA, servo, motion control, robotics, vision, and equipment communication issues.
• Supporting automated equipment used for aseptic formulation, sterile filling, vials, syringes, cartridges, flexible containers/bags, inspection, labeling, packaging, serialization, and aggregation.
• Diagnose and resolve automation-related downtime events to support production schedules.
• Provide on-floor engineering support during startup, shutdown, changeover, and active manufacturing operations.
• Develop, modify, test, and troubleshoot PLC and HMI applications in accordance with site standards and change control requirements.
• Support PLC platforms such as Allen-Bradley / Rockwell Automation, Siemens, or equivalent systems.
• Support HMI/SCADA platforms such as Factory Talk View, WinCC, Ignition, iFIX, Wonderware, or similar systems.
• Review and interpret ladder logic, function block diagrams, structured text, control narratives, electrical drawings, and automation design documentation.
• Maintain current backups of validated automation programs and configuration files.
• Ensure automation work is performed in compliance with cGMP, GDP, data integrity, 21 CFR Part 11, computerized system validation, and company quality system requirements.
• Support validation deliverables including user requirements specifications, functional specifications, design specifications, configuration specifications, commissioning protocols, IQ/OQ/PQ protocols, traceability matrices, and validation summary reports.
• Partner with Validation and Quality Assurance to ensure automation changes are properly assessed, tested, documented, and approved.
• Maintain the validated state of computerized and automated…