Senior Automation Engineer – GMP DeltaV Expert (On-Site)

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

Job summary

Novartis is seeking a Senior Automation Engineer to lead the automation design team at the Durham, NC facility. This on-site role requires technical SME expertise in process automation and GMP manufacturing, with responsibilities spanning design, commissioning, qualification, and lifecycle documentation.

You will collaborate with Quality and a range of partners to ensure compliant manufacturing, participate in regulatory audits, and drive continuous improvement while supporting 24x7 operations

Qualifications

• BS degree or higher in engineering or a related field.
• 8+ years of pharma GMP operations experience (or equivalently 12+ years).
• Excellent written and oral communication skills.
• Experience with system qualification testing and qualification plans with CQ teams.

Responsibilities

• Ensure automation aspects of new equipment are designed to Novartis standards and properly commissioned and qualified.
• Provide oversight for automation across projects, including third-party equipment integration.
• Design, configure, install and maintain automation software and hardware for existing equipment and processes.
• Prepare scopes of work for large projects, lead small teams and manage automation contractors.
• Lead discussions with business partners on priorities, timelines and information sharing.
• Develop and maintain lifecycle documentation (URS, FS, DDS/HDS/SDS).
• Develop and maintain GMP procedures to meet CFRs and internal policies.
• Support new product implementation from development into GMP manufacturing.
• Drive operational excellence and continuous improvement.
• Partner with Quality to ensure a compliant manufacturing environment and support regulatory audits.
• Solve technical issues impacting production and support 24x7 on-site operations.
• Travel up to 10% may be required.

Skills

Automation design leadership

GMP / 21 CFR Part 11 knowledge

DCS / BMS / PLC / SCADA experience

Project management

Technical writing

Communication skills

S88 methodology

On-site manufacturing experience

Education

Bachelor's degree in Engineering or related field

Tools

DCS

BMS

PLC

SCADA

Historian

Infrastructure

Job description

Novartis is seeking a Senior Automation Engineer to lead the automation design team at the Durham, NC facility. This on-site role requires technical SME expertise in process automation and GMP manufacturing, with responsibilities spanning design, commissioning, qualification, and lifecycle documentation.

You will collaborate with Quality and a range of partners to ensure compliant manufacturing, participate in regulatory audits, and drive continuous improvement while supporting 24x7 operations