Automation & Controls Engineer

Indivior in; Raleigh (NC); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

401(k) Plan

Profit Sharing

Medical Coverage

Tuition Reimbursement

HSA options

Wellness programs

Job summary

Indivior is seeking an Automation & Controls Engineer to sustain reliable GMP manufacturing operations. You will design, implement, and validate PLC/SCADA/BMS interfaces, ensuring data integrity and regulatory compliance (21 CFR Part 11).

You will collaborate with Manufacturing, Quality, Validation, Facilities, and Supply Chain for safe, robust automation and audit-ready documentation. Responsibilities include supporting FAT/SAT, IQ/OQ/PQ, and CSA/CSV, as well as developing automation standards,

Qualifications

• Bachelor’s degree in engineering or related field with GMP automation experience preferred.
• Minimum years of GMP automation experience tied to degree level.
• Experience with validation/CSA of GxP computerized systems and change control.

Responsibilities

• Provide daily automation support for manufacturing and GMP utilities to ensure safe, compliant operations.
• Design, configure, and implement control system changes in PLC/SCADA/DCS/BMS platforms per change control and data integrity requirements.
• Lead or support automation scope for new equipment: draft URS/FS/DS, participate in vendor selection, conduct FAT/SAT, IQ/OQ/PQ with Validation/Quality.
• Own or support CSA/CSV for GxP systems; develop risk assessments, test plans, and traceability per GAMP 5.

Skills

Automation support

PLC/SCADA/HMI

GxP compliance

CSA/CSV/Validation

OT cybersecurity awareness

Education

Bachelor's degree in Engineering

Associate degree + 7+ years GMP automation

High School Diploma + 9+ years GMP automation

Tools

OSIsoft PI/AVEVA

Wonderware/AVEVA

BMS/EMS platforms

ISA-88/ISA-95 standards

Job description

WHO WE ARE

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

POSITION OVERVIEW

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.

HOW YOU'LL MAKE AN IMPACT

• 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.

WHAT YOU'LL BRING

• Bachelor's degree in Electrical, Chemical, Mechanical, or Industrial Engineering, Mechatronics, Computer Engineering, or related field from an accredited institution. (PREFERRED)
• 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.

PHYSICAL REQUIREMENTS

• 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.
• Preferred: exposure to MES/EBR integration, historians (OSIsoft PI/AVEVA), recipe management, and alarm rationalization.
• Preferred: knowledge of cybersecurity for OT (ISA/IEC 62443) and GMP critical utilities (BMS/EMS, WFI, clean steam, HVAC for cleanrooms).

HOW WE INVEST IN OUR PEOPLE

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 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

OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behavior.

Employee Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled are encouraged to apply!

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.