Plant IT Specialist

3 days ago

Hubli, Karnataka, India beBeeIT Full time ₹ 8,00,000 - ₹ 15,00,000
Job Title: Plant IT - Pharma

We are seeking a highly skilled and experienced professional to manage all IT operations at the manufacturing plant. The ideal candidate will have strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.

  • The successful candidate will provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA, etc.) and ensure proper documentation and validation protocols are followed.
  • They will also act as the primary IT contact for plant and quality assurance teams, providing technical expertise and support.
  • An additional responsibility will be to support audits and inspections by regulatory bodies (FDA, EMA, etc.) by providing required documentation and demonstrating compliance.
  • Furthermore, the candidate will be responsible for managing local infrastructure (servers, networks, desktops, printers) and coordinating with central IT teams for enterprise-level support.
  • Implementing and monitoring cybersecurity protocols in the plant environment will also be an essential task.
  • Additionally, they will coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations.
  • Maintaining and updating IT SOPs in compliance with GxP standards is another key responsibility.
  • The candidate will also collaborate with vendors and third-party service providers for support and maintenance of plant systems.
  • Last but not least, they will train and support end-users on relevant IT systems and best practices.
Requirements & Qualifications:
  • A bachelor's degree in computer science, Information Technology, or a related field is required.
  • At least 3 years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment, is necessary.
  • Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements is a must.
  • Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a GMP environment is required.
  • Familiarity with ITIL processes and system validation life cycle (SDLC) is also necessary.
  • Strong troubleshooting, analytical, and communication skills are essential.
  • Ability to manage projects and coordinate cross-functional teams is required.
  • Experience with audit readiness and participation is a strong advantage.

If you're passionate about delivering high-quality solutions and working collaboratively in a fast-paced environment, we encourage you to submit your application.

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