OT/IT Engineer - Compliance

Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and provide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world.

The position is located in Dubai, UAE, and reports directly to the IT Head at Acino Pharmaceuticals FZ LLC, UAE. This role is primarily responsible for providing comprehensive OT systems support and for providing basic technical support for IT systems, ensuring seamless operations and regulatory compliance across the organization.

The ideal candidate should possess solid technical expertise and have experience working with OT and IT systems in a manufacturing environment in accordance with various regulatory standards, and a collaborative mindset, working closely with various departments to maintain compliance, support OT/IT infrastructure, and enhance internal controls in line with Acino's global policies and reporting standards.

Key Responsibilities include:

• Serve as the primary contact for OT support and general IT issues, handling breakdowns, logging tickets, resolving problems, and coordinating with external partners when necessary.
• Manage user administration, access control, and password management for GxP OT/IT systems, including IPC, HMI, and PLCs on manufacturing and quality control equipment/instruments.
• Support computer system validation in compliance with GAMP5, EU Annex 11, 21 CFR Part 11, and GxP regulations.
• Develop and maintain Standard Operating Procedures (SOPs) and QMS documentation, including handling deviations, change controls, CAPA, risk assessments, and investigations.
• Prepare and execute validation protocols (IQ, OQ, PQ), user requirements, functional specifications, and related test cases.
• Perform regular data backups, monitor backup operations (especially for manufacturing and quality OT systems and servers), verify data integrity, and escalate issues when needed.
• Conduct audit trail reviews and user access checks to ensure compliance.
• Have a basic understanding of Cisco network environments, IT infrastructure (on-prem & cloud), Azure, Intune, Active Directory, firewall management, and Office 365.
• Install and configure systems for end users and provide basic hardware/software troubleshooting.
• Assist in IT hardware and software procurement.
• Maintain an up-to-date OT/IT asset inventory.

Your Profile:

Bachelor's degree in information technology or Engineering Diploma (3 years +).

Minimum of 5 years of experience preferred.

Knowledge of Manufacturing and Quality related computerized systems.

Understanding various Regulatory requirements related to IT systems.

Experience in computer system validation (CSV).

Good communication and problem-solving skills.

Ability to work independently as well as part of a team.