ITOT Engineer

Scorpion Therapeutics; Carlsbad (CA); On-site; USD 105,000 - 145,000; Full time

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.

Skills

GMP compliance

Regulatory knowledge

Root cause analysis

Cross-functional communication

Education

Bachelor’s degree in Engineering/Automation/Electrical/Computer Engineering/Computer Science or related field

Tools

Allen-Bradley PLC

Siemens PLC

MES

PI Historian

Job description

Key Responsibilities:

• Support, troubleshoot, and enhance ITOT systems including PLCs, HMIs, EMS, BMS, and PC-based control applications; manage user access and account administration.
• Maintain IT/OT infrastructure (servers, virtual machines, network devices, application hosting, backup/disaster recovery) and coordinate with IT on cybersecurity and system integrity.
• Support Computer System Validation (CSV), including IQ/OQ protocol generation and execution.
• Support GMP documentation (deviations, change controls, CAPAs, validation protocols, risk assessments) aligned with 21 CFR Part 11 and GxP; participate in audits/inspections.
• Support technical investigations and root cause analysis for system failures and deviations; drive continuous improvement.
• Support ITOT/digital transformation projects from concept through commissioning, including FAT/SAT, aligned with GMP and safety/engineering standards.
• Drive digital transformation initiatives including AI, process automation, and robotics.
• Support CAPEX projects to install, qualify, and commission new production lines; coordinate ITOT scope with engineering, PM, and vendors.
• Provide essential on-call coverage on a rotation basis for a 24/7 manufacturing facility.

Requirements:

• Bachelor’s degree in Engineering/Automation/Electrical/Computer Engineering/Computer Science or related field.
• 2–3 years hands‑on experience with PLC or DCS manufacturing control systems; familiarity setting up OT‑supporting IT infrastructure (PLC/DCS/MES/PI Historians).
• 2–3 years in pharmaceutical/biotech with strong GMP and regulatory compliance knowledge.
• Proficiency with PLCs (Allen-Bradley, Siemens) or DCS; familiarity with MES.
• Working knowledge of EMS/BMS and industrial networking.
• Understanding of GMP/GxP, 21 CFR Part 11, and CSV/CSA (IQ/OQ).
• Familiarity with change control, CAPA, and root cause analysis.
• Effective communication across teams/vendors; fluency in English.