IT/OT Systems Engineer – GMP, AI & Digital Ops

Scorpion Therapeutics

Carlsbad (CA)

On-site

USD 105,000 - 145,000

Full time

5 days ago

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Job summary

Scorpion Therapeutics in Carlsbad, California, is seeking an IT/OT Engineer to support and enhance GMP-compliant control systems across manufacturing facilities. You will troubleshoot PLCs/DCS, manage IT/OT infrastructure, and contribute to CSV/validation activities.

The role covers audit support, change controls, CAPAs, root cause analysis, and digital transformation initiatives including AI and automation.

Qualifications

Bachelor’s degree in Engineering/Automation/Electrical/Computer Engineering/CS or related field.
2–3 years hands-on experience with PLC or DCS manufacturing control systems.
Pharma/biotech GMP exposure and regulatory compliance knowledge.
Familiar with CIM/CSV concepts and IT/OT integration.

Responsibilities

Support, troubleshoot, and enhance ITOT systems including PLCs, HMIs, EMS, BMS, and PC-based control applications.
Maintain IT/OT infrastructure and coordinate with IT on cybersecurity and system integrity.
Support CSV activities including IQ/OQ protocol generation and execution.
Support GMP documentation, deviations, change controls, CAPAs, validation protocols, risk assessments.
Assist in audits/inspections and root-cause analysis for deviations.
Drive ITOT/digital transformation projects from concept through commissioning (FAT/SAT).
Lead digital transformation initiatives including AI, process automation, and robotics.
Support CAPEX projects to install/qualify new production lines; coordinate ITOT scope with engineering.
Provide on-call coverage for a 24/7 manufacturing facility.