Automation & Controls Engineer- Aseptic & Packing Systems

Job description

**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. **Job Location:** Nivagen Pharmaceuticals 3900 Duckhorn Dr, Sacramento, CA 95834. **About the Job:** 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. **Responsibilities:** - 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 FactoryTalk 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 systems. - Support audit readiness for automation-related systems and records. - Support automation integration for new and existing manufacturing equipment. - Work with OEMs and internal teams during equipment design, FAT, SAT, commissioning, qualification, and startup. - Support equipment interfaces with MES, ERP/SAP, SCADA, data historians, serialization systems, vision inspection systems, and building automation systems. - Troubleshoot communication protocols such as Ethernet/IP, Profinet, Modbus, OPC, serial communication, and industrial network connectivity. - Support alarm configuration, data collection, recipe management, batch reporting, and equipment status reporting. - Support automation systems associated with isolators, Restricted Access Barrier Systems, vial filling lines, syringe filling lines, cartridge filling systems, flexible container/bag filling systems, cappers, labelers, cartoners, case packers, conveyors, vision inspection systems, and serialization/aggregation equipment. - Support VHP cycle automation, environmental monitoring interfaces, equipment alarms, and electronic records where applicable. - Partner with Manufacturing and Maintenance to resolve recurring automation or equipment control issues. - Support packaging line control systems, printer/labeler interfaces, barcode verification, serialization reporting, and aggregation workflows. - Help maintain equipment controls in an inspection-ready and production-ready state. - Initiate, assess, and execute automation-related change controls in accordance with site procedures. - Support investigations for deviations, equipment failures, batch interruptions, automation alarms, data integrity concerns, and system performance issues. - Participate in root cause analysis and develop corrective and preventive actions related to control systems. - Document technical assessments, impact evaluations, test results, and implementation plans. - Ensure automation changes are properly reviewed, approved, tested, and closed. - Support automation preventive maintenance activities, including backup verification, network health checks, control cabinet inspections, UPS checks, and HMI/PLC health monitoring. - Identify opportunities to improve equipment reliability, uptime, alarm management, and system robustness. - Analyze recurring automation failures and recommend long-term corrective actions. - Support spare parts strategy for control system components. - Participate in reliability improvement and continuous improvement projects. - Support compliance with data integrity expectations for electronic records, audit trails, user access, time synchronization, recipe management, and backup/restore controls. - Partner with IT/OT teams to maintain secure, reliable industrial control system networks. - Support user access reviews, account management, system backup, patching, disaster recovery, and cybersecurity initiatives. - Ensure automation systems are maintained in accordance with company IT/OT standards and GMP requirements. - Support system lifecycle management, obsolescence planning, and periodic review activities. - Create and maintain automation documentation including control narratives, functional specifications, system architecture diagrams, network diagrams, I/O lists, alarm lists, recipe/configuration documentation, and backup/recovery procedures. - Maintain automation-related SOPs, work instructions, troubleshooting guides, and support documentation. - Ensure technical documentation reflects current system configuration and validated state. - Support training for Maintenance, Manufacturing, Engineering, and other system users. - Provide technical standards input for new equipment and automation projects. **Education/Experience:** - Bachelor’s degree in Electrical Engineering, Automation Engineering, Controls Engineering, Computer Engineering, Mechanical Engineering, Chemical Engineering, or related technical discipline required. - Equivalent combination of education, training, and relevant automation experience may be considered. - Minimum of 3–5 years of automation, controls, or manufacturing engineering experience in a regulated manufacturing environment preferred. - Experience supporting pharmaceutical, biotechnology, medical device, food, chemical, or other GMP-regulated manufacturing operations preferred. - Experience with PLC/HMI troubleshooting, programming, and system support required. - Experience supporting automated manufacturing or packaging equipment preferred. **Preferred Qualifications:** - Experience in sterile manufacturing, aseptic fill/finish, biologics, parenteral manufacturing, or packaging operations. - Experience with isolators, RABS, VHP systems, filling lines, inspection systems, labeling systems, serialization systems, or packaging automation. - Experience with platforms such as Allen-Bradley / Rockwell Automation, Siemens, FactoryTalk View, WinCC, Ignition, Wonderware, OSIsoft PI or other data historians, Cognex, Keyence, Antares, Optel, TraceLink, or similar systems. - Experience with MES, SAP, ERP interfaces, and electronic batch record systems. - Experience with 21 CFR Part 11, GAMP 5, computerized system validation, and audit trail review. - Experience supporting FAT, SAT, IQ, OQ, PQ, and process validation. - Experience with industrial cybersecurity, OT networks, virtualized systems, and backup/recovery strategies. - Lean Six Sigma, ISA, Rockwell, Siemens, or automation-related certifications preferred. **Physical Requirements/ Working Conditions:** - Ability to sit, stand, walk, bend, reach, kneel, and climb as needed to access equipment and control panels. - Ability to work at a computer workstation for extended periods. - Ability to visually inspect equipment screens, control panels, wiring, labels, documentation, and HMI displays. - Ability to lift, carry, push, or pull tools, laptops, test equipment, or components up to 25–50 pounds, in accordance with site safety procedures. - Ability to wear required PPE, including cleanroom gowning, safety glasses, gloves, hearing protection, or other protective equipment. - Ability to enter cleanrooms, manufacturing suites, packaging areas, utility spaces, and equipment rooms as required. - Ability to work overtime, weekends, holidays, alternative shifts, or on-call support as business needs require. **Work Environment** - Work is performed in a GMP pharmaceutical manufacturing facility, including office areas, manufacturing areas, cleanrooms, packaging areas, equipment rooms, and utility areas. - Work may occur near operating equipment, automated machinery, electrical panels, moving parts, compressed air, controlled environments, and production materials. - The role may require entry into Grade B, Grade C, Grade D, and controlled support areas, depending on production and equipment needs. - Strict adherence to GMP, safety, gowning, contamination control, lockout/tagout, electrical safety, and documentation procedures are required. - This position requires on-site presence; limited remote work may be possible depending on business needs and company policy. **Schedule / Shift Requirements** - Standard business hours are typical, but support may be required outside normal hours based on production needs. - Overtime, weekends, holidays, shutdown coverage, project support, and on-call support may be required. - Must be able to support urgent equipment issues, manufacturing campaigns, validation activities, and planned maintenance windows. **Requirements:** - Must have experience in Pharmaceutical Manufacturing - Valid driver’s license and acceptable driving record - Legally authorized to be employed in the United States - Must live or be willing to move to the Sacramento Metropolitan Region (Approx 40 miles’ radius) **Benefits:** - Competitive Salary: Based on Experience - Yearly bonus eligibility - Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being, including medical, dental, and vision coverage - Sick Time/PTO **Additional Information:** Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.