GMP Automation & Controls Engineer

Indivior PLC

Raleigh (NC)

On-site

USD 98,000 - 116,000

Full time

14 days+

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Benefits offered by this job

Starting Salary: $98,000-$115,500

Competitive PTO + company closure

Job summary

Indivior PLC in Raleigh, NC is seeking an Automation & Controls Engineer to ensure reliable, compliant operation of GMP systems. You will design, implement, validate, and maintain PLC/SCADA/DCS/BMS/EMS interfaces, instrumentation, and automation solutions.

The role partners with Manufacturing, Quality, Validation and Facilities to maximize uptime, data integrity, and yield while meeting 21 CFR Part 11, Annex 11, and GAMP 5.

Qualifications

5+ years of GMP automation experience in pharma/biotech manufacturing.
Experience with validation/CSA of GxP computerized systems (GAMP 5).
Experience leading FAT/SAT and IQ/OQ/PQ for process equipment and utilities.
Familiarity with ISA-88/ISA-95, data integrity (ALCOA+), and 21 CFR Part 11.

Responsibilities

Provide daily automation support to ensure safe, compliant operations.
Design, configure, and implement control system changes in PLC/SCADA/DCS/BMS/EMS.
Own or support CSA/CSV for GxP systems and maintain validated state.
Develop automation standards, backups, version control, and alarm management.
Integrate data flows among MES/EBR, LIMS, historians, and enterprise systems.

Skills

PLC Programming

SCADA

HMI

Instrumentation

GMP Automation

Education

Bachelor's degree in Engineering

Associate's degree in related field

Tools

Allen-Bradley

Siemens

Ignition/AVEVA

BMS/EMS

OSIsoft PI/AVEVA Historian

Job description

The role partners with Manufacturing, Quality, Validation and Facilities to maximize uptime, data integrity, and yield while meeting 21 CFR Part 11, Annex 11, and GAMP 5.

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