GMP Automation & Controls Engineer

Indivior; Raleigh (NC); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Bonus program

Long-Term Incentive Plan

401(k) match

Comprehensive medical, dental, vision

Paid time off

Tuition reimbursement

Job summary

Indivior is seeking an Automation & Controls Engineer to ensure reliable operation of manufacturing and GMP utilities. You will design, implement, and validate control systems (PLC/SCADA/DCS) to maximize uptime and data integrity in a fast-paced pharmaceutical environment.

Collaborating with Manufacturing, QA, Validation, Facilities, and Supply Chain, you will lead or support URS/FS/DS, participate in FAT/SAT, and help ensure compliance with 21 CFR Part 11, Annex 11, and GAMP 5.

Qualifications

• Minimum 5 years of GMP automation experience in pharma/biotech.
• Hands-on PLC/SCADA/HMI programming and troubleshooting.
• Experience with GxP validation, change control, and data integrity (ALCOA+).

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.
• Lead or support FAT/SAT IQ/OQ/PQ activities in collaboration with Validation and QA.
• Develop and maintain automation standards, code libraries, and alarm management.
• Support CSA/CSV for GxP systems and maintain audit-ready documentation.

Skills

PLC/SCADA/HMI programming

Instrumentation

GxP validation

ALCOA+ data integrity

Cybersecurity for OT

URS/FS/DS documentation

Change control

Automation standards

MES/EBR integration

Batch control ISA-88

Education

Bachelor’s degree in Electrical/Industrial/Mechatronics Engineering

Associate’s degree + 7+ years GMP automation experience

High School Diploma + 9+ years GMP automation experience

Tools

Allen-Bradley

Siemens

Ignition

Wonderware/AVEVA

OSIsoft PI/AVEVA Historian

BMS/EMS

Job description

Indivior is seeking an Automation & Controls Engineer to ensure reliable operation of manufacturing and GMP utilities. You will design, implement, and validate control systems (PLC/SCADA/DCS) to maximize uptime and data integrity in a fast-paced pharmaceutical environment.

Collaborating with Manufacturing, QA, Validation, Facilities, and Supply Chain, you will lead or support URS/FS/DS, participate in FAT/SAT, and help ensure compliance with 21 CFR Part 11, Annex 11, and GAMP 5.