Plant Information Technology Executive

Plant IT Director

The Plant IT Director will be responsible for leading the overall IT infrastructure, applications, and systems for plant operations. This includes supporting, maintaining, and enhancing IT operations required to meet manufacturing and compliance needs.

This role will lead the site IT team for routine tasks, collaborate with cross-functional teams and headquarters departments for system improvements, CAPAs, and new projects implementation. The ideal candidate will have a proven track record of heading IT systems in medium to large-scale formulations or API manufacturing facilities.

Key Responsibilities:

• Design, implement, and maintain robust infrastructure and systems to support various internal functions like production, engineering, quality control, and warehouse operations.
• Oversee the installation, configuration, and management of servers to ensure optimal performance and reliable operations.
• Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
• Understand pharmaceutical processes and their importance on product quality and safety.
• Ensure all IT systems comply with industry regulations and standards, particularly those relevant to GxP standards.
• Maintain good documentation practices for IT infrastructure, applications, configurations, and procedures.
• Ensure information security measures, including cyber security protocols and privacy security standards to protect sensitive data.
• Collaborate with cross-functional teams and headquarters departments for any system issues, improvements, CAPAs, and new projects implementation.
• Diagnose and resolve technical issues related to IT systems, providing timely support to minimize downtime and conducting root cause analysis for specified issues.
• Handle data backup of all critical systems and be conversant with online backup systems like Veeam and Acronics.
• Have experience with major audits like US FDA, MHRA, TGA, and be familiar with relevant guidelines and compliance standards.
• Have knowledge of cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11.
• Assess systems gaps applicable to user management, data backup, systems hardware, software, and implement corrective actions.
• Have good exposure to L1 systems upgrade and L2 integration, such as DAS/Historian, and be familiar with OT-IT integration technologies like Kepware Gateway for PLC & IPC integration with central DAS systems.
• Knowledge of quality management systems, with good exposure to change controls, incidents, deviations handling, RA & CAPA is a must.
• Awareness of Industry 4.0 strategies and smart manufacturing initiatives will be an advantage.

Technical & Preferred Skills:

• Proficiency in server management (Windows, Linux, etc.).
• Strong knowledge of active and passive networking (LAN/WAN, switches, routers, firewalls).
• Expertise in information security, cyber security, and privacy security.
• Knowledge in pharmaceutical manufacturing and quality process.
• Adequate knowledge of OT-IT systems integration (L1 & L2 systems, DAS, Historian).
• Exposure to various IT applications like SAP, eBMR, MES, QMS, LIMS, etc.
• Ability to work in a cross-functional and challenging environment.
• Capable of idea generation and process improvement skills.
• Exposure to regulated audits like US FDA, MHRA, etc.
• Certifications such as CISSP, CISM, CCNA, or equivalent are desirable.
• Experience with cloud infrastructure (AWS, Azure, etc.).
• Knowledge of virtualization technologies (VMware, Hyper-V, etc.).
• Good project management and exposure to computerized systems validation.

Educational Qualification:

Bachelor's degree in Computer Science, Information Technology, or related field from a reputable institution.

Experience:

15 to 20 years of relevant experience in IT leadership and management.