Senior DeltaV Automation Engineer – GMP Drug Product

Scorpion Therapeutics; Durham (NC); On-site; USD 109,000 - 202,000; Full time

Benefits offered by this job

Health, life & disability insurance

401(k) with match

Paid time off

Job summary

Scorpion Therapeutics in Durham, NC seeks an Automation Engineer to lead and execute automation programs for manufacturing processes, ensuring equipment meets GMP requirements and is commissioned and qualified.

You will oversee integration of third-party equipment with DCS/BMS/SCADA, design and maintain software/hardware, and drive continuous improvement. Travel up to 10% is possible; strong communication with Quality and regulatory teams is essential.

Qualifications

• B.S. in Engineering/Computer Science/related field.
• 8 years GMP pharmaceutical/biopharma manufacturing experience (or 12 years equivalent).
• Excellent oral/written communication and technical writing.
• Programming, troubleshooting, and maintenance experience with DCS, BMS, PLC, SCADA, historians, infrastructure, and industrial protocols.
• Qualification testing experience; guidance on qualification plans with C&Q.
• Proven S88 experience and control system standards aligned to S88.
• Field wiring practices/panel design; troubleshooting/start-up; instrumentation experience.
• Experience with complex change controls.
• In-depth FDA/21 CFR Part 11 and GMP knowledge.
• Strong project management and long-term planning skills.
• Ability to prepare contingency plans and work through complex issues under pressure.
• Up to 10% travel may be required.

Responsibilities

• Ensure automation aspects of new equipment are designed to Novartis standards and are commissioned and qualified.
• Provide oversight for automation project work, including integration of 3rd-party equipment with standard plant systems (e.g., DCS, BMS, Historian, infrastructure).
• Design, configure, install, and maintain automation software and associated hardware for existing equipment/processes.
• Prepare scopes of work, lead small teams, and manage automation contractors to meet project timelines.
• Lead discussions with internal partners on priorities, timelines, and information sharing.
• Develop, review, and approve lifecycle documentation (URS, FS, DDS/HDS/SDS).
• Develop/maintain procedures to meet GMP, CFRs, and internal policies.
• Participate/lead new product implementation to transition into GMP manufacturing.
• Drive operational excellence and continuous improvement.
• Partner with Quality; participate in regulatory audits as an automation SME.
• Solve technical issues impacting production.
• Support 24x7 operations with rotating on-call.
• Support investigations of automation non-conformances.

Skills

GMP knowledge

Project management

Communication skills

Problem solving

Automation programming

Education

B.S. in Engineering/Computer Science/related field

Tools

DCS

BMS

PLC

SCADA

Historians

Industrial protocols

Job description

Scorpion Therapeutics in Durham, NC seeks an Automation Engineer to lead and execute automation programs for manufacturing processes, ensuring equipment meets GMP requirements and is commissioned and qualified.

You will oversee integration of third-party equipment with DCS/BMS/SCADA, design and maintain software/hardware, and drive continuous improvement. Travel up to 10% is possible; strong communication with Quality and regulatory teams is essential.