Automation & Controls Engineer

Indivior • Raleigh, NC

9d • Onsite

About The Position

As an Automation & Controls Engineer, you will ensure reliable, compliant, and efficient operation of manufacturing and GMP utility control systems. You will design, implement, maintain, and validate PLC/SCADA/DCS/BMS/EMS/MES interfaces, instrumentation, and automation solutions supporting drug substance manufacturing operations. This role exists to maximize uptime, throughput, and data integrity while meeting 21 CFR Part 11, Annex 11, and GAMP 5/CSA expectations. You will partner with Manufacturing, Quality, Validation, Facilities/Utilities, and Supply Chain to deliver safe, robust, and audit-ready automation.

Requirements

• Bachelor’s degree in Electrical, Chemical, Mechanical, or Industrial Engineering, Mechatronics, Computer Engineering, or related field from an accredited institution.
• Minimum 5 years of experience in pharmaceutical or biotech GMP manufacturing automation and controls, including hands-on PLC/SCADA/HMI programming, instrumentation, and troubleshooting.
• Demonstrated experience with validation/CSA of GxP computerized systems (GAMP 5), change control, deviations/CAPAs, and maintaining validated state.
• Experience leading FAT/SAT and IQ/OQ/PQ for process equipment and utilities.
• Familiarity with batch control (ISA-88), system integration (ISA-95), data integrity (ALCOA+), and Part 11/Annex 11 compliance.

Nice To Haves

• Associate’s degree in a related field with 7+ years of directly relevant GMP automation experience; or High School Diploma with 9+ years of directly relevant GMP automation experience.
• Exposure to MES/EBR integration, historians (OSIsoft PI/AVEVA), recipe management, and alarm rationalization.
• Knowledge of cybersecurity for OT (ISA/IEC 62443) and GMP critical utilities (BMS/EMS, WFI, clean steam, HVAC for cleanrooms).

Responsibilities

• Provide daily automation support for manufacturing and GMP utilities to ensure safe, compliant, and continuous operations; triage alarms, troubleshoot PLCs/HMIs, instrumentation, and networked controls; resolve deviations to restore service and prevent recurrence.
• Design, configure, and implement control system changes in PLC/SCADA/DCS/BMS/EMS platforms (e.g., Allen-Bradley, Siemens, Ignition, Wonderware/AVEVA, Johnson Controls/Siemens BMS) in accordance with change control, cyber, and data integrity requirements.
• Lead or support automation scope for new equipment and modifications: author and review URS/FS/DS, participate in vendor selection, conduct FAT/SAT, and plan and execute IQ/OQ/PQ in collaboration with Validation and Quality.
• Own or support Computer Software Assurance/Validation (CSA/CSV) for GxP systems; develop risk assessments, test plans, traceability, and reports per GAMP 5 and site SOPs; maintain validated state through periodic review.
• Develop and maintain automation standards, code libraries, alarm rationalization, and historian tags; implement robust backups, disaster recovery, version control, and patch management.
• Integrate and sustain data flows among MES/EBR, LIMS, historians, and enterprise systems to ensure ALCOA+ data integrity and timely release; build dashboards for process monitoring, OEE, and deviations trending.
• Partner with Manufacturing Science and Technology transfer and scale-up; translate process requirements into control strategies, instrumentation specifications, interlocks, and recipes to achieve quality and yield targets.
• Support root cause analysis as principal or co-investigator for automation-related deviations and equipment failures; author effective CAPAs and effectiveness checks; implement error-proofing and alarm management improvements.
• Oversee automation aspects of critical utilities and facilities (HVAC for cleanrooms, BMS/EMS, WFI, clean steam, compressed air, CIP/SIP) to maintain environmental control and compliance with site classifications and monitoring.
• Ensure compliance with FDA/EMA, 21 CFR Part 11, Annex 11, Data Integrity, OSHA, and ISA/IEC 62443 cybersecurity practices; maintain audit-ready documentation, drawings (P&IDs, loop sheets), and SOPs.
• Train operators, maintenance, and peers on systems, SOPs, and troubleshooting; provide on-call support coverage as needed for a small-site environment.

Benefits

• Competitive PTO plus company closure from December 24th- January 1st
• Eligible to participate in Indivior’s bonus program, based on company and individual performance
• Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan
• 401(k) and Profit-Sharing Plan- Company match
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Wellness programs as well as other discounts and perks

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level