GMP Automation & Controls Engineer

Indivior in

Raleigh (NC)

On-site

USD 110,000 - 150,000

Full time

2 days ago

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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.