Senior IT Director for Manufacturing Facilities

3 days ago

Palakkad, Kerala, India beBeeITDirector Full time ₹ 45,00,000 - ₹ 90,00,000

Job Description:

We are seeking a highly experienced Senior IT Director to lead our Manufacturing Facilities' IT teams. The ideal candidate will have a proven track record of heading IT systems in a medium to large-scale formulations or API manufacturing facility.

The successful candidate will be responsible for designing, implementing, and maintaining robust infrastructure & systems to support various internal functions like production, engineering, quality control, and warehouse management within the manufacturing facility. This includes overseeing the installation, configuration, and management of servers, ensuring optimal performance for reliable operations.

Key Responsibilities:

  • Manage active and passive networking components, including switches, routers, firewalls, and cable systems.
  • Understand pharmaceutical processes and their importance on product quality & 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 HO 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 conducting RCA for specified issues.
  • Handle data backup of all critical systems and be conversant with online backup systems like Veeam and Acronics.
  • Familiarity with major audits like US FDA, MHRA, TGA, etc., and relevant guidelines and compliance standards.
  • Good knowledge of 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.
  • Familiarity with OT-IT integration technologies like Kepware Gateway for PLC & IPC integration with central DAS systems.
  • Awareness of Industry 4.0 strategies and Smart Mfg initiatives is an advantage.

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 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:

B.Tech/B.E/B.Sc./BCA or above from a reputed institute.

Experience: 15 to 20 years of relevant experience.

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