Plant Operations IT Infrastructure Manager

Job Title: IT Plant Head

As a key member of the site team, you will be responsible for heading the overall IT infrastructure, applications, and systems for plant operations.

• Support, maintain, and enhance IT operations to meet manufacturing and compliance needs.
• Lead the site IT team in routine tasks and collaborate with cross-functional teams for system improvements and digital projects.

The ideal candidate has 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 & systems to support production, engineering, QC & warehouse functions.
• Oversee server installation, configuration, and management for optimal performance.
• Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
• Understand pharmaceutical processes and their impact on product quality & safety.
• Ensure all IT systems comply with industry regulations and standards, particularly GxP.
• Maintain good documentation practices for IT infrastructure, applications, configurations, and procedures.
• Implement information security measures, including cyber security protocols and privacy security standards to protect sensitive data.
• Collaborate with cross-functional teams for system issues, improvements, CAPAs, and new project implementation.
• Diagnose and resolve technical issues related to IT systems, providing timely support to minimize downtime.
• Handle data backup of critical systems and be conversant with online backup systems like Veeam and Acronics.
• Experience major audits like US FDA, MHRA, TGA, and familiarity with relevant guidelines and compliance standards.
• Good knowledge of cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11.
• Assess system gaps applicable to user management, data backup, systems hardware, software, and implement corrective actions.
• Exposure to L1 systems upgradation and L2 integration like DAS/Historian. Familiarity with OT-IT integration technologies like Kepware Gateway for PLC & IPC integration.
• Knowledge of quality management systems with exposure into change controls, incidents & deviations handling, RA & CAPA.
• Awareness of Industry 4.0 strategies and smart mfg initiatives is an advantage.

Requirements:

• Proficiency in server management (Windows, Linux).
• 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.
• 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.
• Certifications like CISSP, CISM, CCNA are desirable.
• Experience with cloud infrastructure (AWS, Azure). Knowledge of virtualization technologies (VMware, Hyper-V).
• Good project management and exposure to computerized systems validation.
• Educational Qualification: B.Tech/B.E/B.Sc./BCA or above from a reputed institute.
• Experience: 15 to 20 years of relevant experience.