ITOT Engineer

About the Role

The ITOT Engineer will join the ITOT team and will be responsible for maintaining, troubleshooting, and supporting ITOT systems to ensure smooth and reliable operation of a 24/7 manufacturing facility. This role supports the installation, commissioning, and ongoing optimization of ITOT systems and equipment, ensuring compliance with safety, regulatory, and quality standards, and provides technical support to minimize downtime and maintain continuous production. The role also contributes to digital transformation efforts within manufacturing operations, supporting initiatives such as AI, process automation, and robotics, and supports CAPEX projects to commission new production lines.

Key Responsibilities

• Support, troubleshoot, and enhance ITOT systems across Manufacturing, Laboratory and Facility applications: PLCs, HMIs, EMS, BMS, and PC-based control systems; vertical integration of Data Historians to shop floor and enterprise systems (MES, SAP); Robotics, Vision System, Industrial Printers.
• Assist with maintaining IT/OT infrastructure (servers, virtual machines, network devices, application hosting, backup and disaster recovery, user access and time synchronization), coordinating with IT teams on cybersecurity and system integrity.
• Support Computer System Validation (CSV) activities, including generation and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols.
• Provide on-call support on a rotation basis to support the 24/7 manufacturing facility.
• Support authoring and review of GMP documentation including deviations, change controls, CAPAs, validation protocols, risk assessments, periodic reviews, SOPs in alignment with 21 CFR Part 11 and GxP requirements.
• Support technical investigations into system failures and deviations, lead root cause analysis and contribute to continuous improvement initiatives.
• Support ITOT and digital transformation projects from concept through commissioning, including FAT/SAT activities.
• Support digital transformation initiatives including AI, process automation, and robotics projects in collaboration with cross-functional teams.
• Support CAPEX projects to install, qualify, and commission new production lines, coordinating ITOT scope with engineering, project management, and vendor teams.

Essential Requirements

• Bachelor's degree in Engineering, Automation Engineering, Electrical Engineering, Computer Engineering, Computer Science, or a related technical discipline.
• 2–3 years of hands-on experience with manufacturing control systems such as PLC or DCS, with familiarity setting up IT infrastructure to support OT technologies such as PLCs, DCS, MES, and PI Historians.
• 2–3 years of experience as ITOT engineer in a manufacturing site.
• Proficiency with PLCs (e.g., Allen-Bradley, Siemens) or Distributed Control Systems (DCS), and familiarity with Manufacturing Execution Systems (MES).
• Working knowledge of EMS/BMS platforms and industrial networking.
• Understanding of GMP/GxP regulations, 21 CFR Part 11, and CSV/CSA methodologies, including IQ/OQ protocol generation and execution.
• Familiarity with Change Control, CAPA processes, and root cause analysis.
• Excellent communication skills with ability to coordinate across multidisciplinary teams and vendors, and fluency in English.

Desirable Requirements

Experience in the pharmaceutical or biotechnology industry with a solid understanding of Good Manufacturing Practices (GMP) and regulatory compliance is highly desirable.