ITOT Engineer

About the role

The ITOT Engineer maintains, troubleshoots and supports ITOT systems so that a 24/7 manufacturing facility runs smoothly and reliably. The role covers installation, commissioning and ongoing optimisation of ITOT systems and equipment, compliance with safety, regulatory and quality standards, and technical support to minimise downtime. It also contributes to digital transformation (AI, process automation, robotics) and to CAPEX projects commissioning new production lines.

Key responsibilities

• Support, troubleshoot and enhance ITOT systems (PLCs, HMIs, EMS, BMS, PC-based control apps), manage user access and run periodic reviews
• Maintain IT/OT infrastructure (servers, virtual machines, network devices, backups, disaster recovery) with IT teams on cybersecurity and system integrity
• Support CSV activities, including generating and running IQ and OQ protocols
• Support GMP documentation (deviations, change controls, CAPAs, validations, risk assessments) under 21 CFR Part 11 and GxP, and take part in audits and inspections
• Support investigations of system failures and deviations, and contribute to continuous improvement
• Support ITOT and digital transformation projects from concept through commissioning, including FAT/SAT
• Support CAPEX projects installing, qualifying and commissioning new production lines
• Provide on-call support on a rotation basis for the 24/7 facility

Required profile

• Bachelor's degree in Engineering, Automation, Electrical, Computer Engineering, Computer Science or a related field
• 2-3 years of hands-on experience with manufacturing control systems (PLC or DCS) and setting up IT infrastructure for OT technologies (PLCs, DCS, MES, PI Historians)
• 2-3 years in the pharmaceutical or biotechnology industry with a solid understanding of GMP and regulatory compliance
• Fluency in English

Required skills

• Proficiency with PLCs (e.g. Allen-Bradley, Siemens) or DCS, and familiarity with MES
• Working knowledge of EMS/BMS platforms and industrial networking
• Understanding of GMP/GxP, 21 CFR Part 11, CSV/CSA (IQ/OQ), change control, CAPA and root cause analysis

What we offer

• Expected salary of $98,700 to $183,300 per year, with a performance-based cash incentive and possible annual equity awards
• Benefits package including health, life and disability coverage, 401(k) with company contribution and match, and a time-off package