Senior Automation Engineer, GMP Pharma Systems (On-Site)

NCBiotech; Durham (NC); On-site; USD 104,000 - 192,000; Full time

Job summary

Novartis in Durham, NC is seeking a Senior Automation Engineer to lead automation design for a aseptic drug product facility. On-site role with responsibilities spanning project leadership, system integration (DCS/BMS/PLC/SCADA), and lifecycle documentation.

The role emphasizes GMP, 21 CFR part 11 knowledge, and partnering with Quality for a compliant manufacturing environment while supporting 24x7 operations. Travel up to 10% may be required.

Qualifications

• Bachelor-level engineering/CS degree or equivalent.
• Strong communication and writing abilities.
• Experience with GMP environments and validation concepts.

Responsibilities

• Lead automation design initiatives for new equipment.
• Oversee integration of third-party equipment with plant systems (DCS, BMS, Historian).
• Develop, review and approve lifecycle documents (URS, FS, DDS/HDS/SDS).
• Ensure GMP compliance and participate in regulatory audits as automation SME.
• Support 24x7 operations and on-call responsibilities.
• Drive continuous improvement and issue resolution in manufacturing.

Skills

Communication skills

Project management

Technical writing

Education

B.S. in Engineering/CS

Tools

DCS

BMS

PLC

SCADA

Historian

Job description

Novartis in Durham, NC is seeking a Senior Automation Engineer to lead automation design for a aseptic drug product facility. On-site role with responsibilities spanning project leadership, system integration (DCS/BMS/PLC/SCADA), and lifecycle documentation.

The role emphasizes GMP, 21 CFR part 11 knowledge, and partnering with Quality for a compliant manufacturing environment while supporting 24x7 operations. Travel up to 10% may be required.