Senior Automation Engineer: BMS/PLC/OEM for GMP

Healthcare Businesswomen’s Association

Durham (NC)

On-site

USD 99,000 - 183,000

Full time

5 days ago

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Benefits offered by this job

Health benefits

Life insurance

Disability benefits

401(k) with company match

Generous leave

Job summary

Novartis is seeking an Automation Engineer III for an on-site role in Durham, NC to support GMP manufacturing systems. You will maintain and improve BMS, PLC, and OEM automation, lead capital project activities, and drive compliance with FDA 21 CFR Part 11.

Responsibilities include design and validation documentation, lifecycle management, and collaboration with Manufacturing and Quality teams to resolve complex production issues. Home office relocation is not provided.

Qualifications

Bachelor's degree in engineering, computer science or related field.
5+ years in pharma/biopharma GMP operations or 9+ years equivalent.
Hands-on experience with DCS platforms (DeltaV preferred).
Experience with PLC, BMS, SCADA/HMI in regulated environments.
Familiarity with FDA 21 CFR Part 11 and validation/change controls.
Knowledge of OSI PI data historians and industrial protocols.

Responsibilities

Maintain, troubleshoot, and optimize BMS, PLC, OEM and other automation systems.
Lead automation activities for capital projects, upgrades, and enhancements.
Develop and maintain validation docs (URS, FS, DDS, HDS, SDS).
Support change controls and regulatory compliance initiatives.
Collaborate with Manufacturing and Quality to resolve complex issues.
Provide on-site support for GMP manufacturing operations.