IT Infrastructure Director

Job Title: IT Infrastructure Director

Experience: 15 plus years required.

Location: Daman.

Type: Full-time opportunity available.

Experience Level: Senior position.

Department: Formulations and API Manufacturing Plant operations.

The purpose of this role is to oversee the overall IT infrastructure, applications, and systems for the plant operations. The ideal candidate will have a proven track record of heading IT systems in a medium to large-scale formulations or API manufacturing facility.

Key Responsibilities:

• Design, implement, and maintain robust infrastructure and systems to support various internal functions like production, engineering, quality control, and warehouse operations within the manufacturing facility.
• Oversee the installation, configuration, and management of servers to ensure optimal performance for reliable operations.
• Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
• Understand pharmaceutical processes and its 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 cybersecurity protocols and privacy security standards to protect sensitive data.
• Collaborate with cross-functional teams and headquarters departments for any systems issues, improvements, CAPAs, and new projects implementation for a unified workflow.
• Diagnose and resolve technical issues related to IT systems providing timely support to minimize downtime and perform 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, etc., and be familiar with relevant guidelines and compliance standards.
• Have good knowledge on cGAMP and compliance requirements like 21 CFR Part 11 and EU-Annexure 11, etc.
• Assess system gaps applicable to user management, data backup, systems hardware, software, and implement corrective actions.
• Have good exposure on L1 systems upgradation and L2 integration like DAS/Historian.
• Be familiar with OTIT integration technologies like Kepware Gateway for PLC & IPC integration with central DAS systems.
• Knowledge on quality management systems with very good exposure into change controls, incidents & deviations handling, RA & CAPA is a must.
• Awareness on Industry 4.0 strategies and smart manufacturing initiatives will be an advantage.

Technical Requirements:

• Proficiency in server management (Windows, Linux, etc.).
• Strong knowledge of active and passive networking (LAN/WAN, switches, routers, firewalls).
• Expertise in information security, cybersecurity, and privacy security.
• Knowledge in pharmaceutical manufacturing and quality process.
• Adequate knowledge of OT-IT systems integration (L1 & L2 systems, DAS, Historian).
• Exposure on 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: B. Tech/B.E/B.Sc./BCA or above from a reputed institute.

Experience: 15 to 20 years of relevant experience required.