IT Specialist

Overview:

The plant information technology specialist is responsible for managing all IT operations at the manufacturing facility, ensuring alignment with corporate IT standards and regulatory requirements.

• Manage all IT operations at the manufacturing facility, ensuring alignment with corporate IT standards and regulatory requirements.
• Provide GxP-compliant support for manufacturing systems (MES, LIMS, SCADA, etc.) and ensure proper documentation and validation protocols are followed.
• Act as the primary IT contact for plant and quality assurance teams.
• Support audits and inspections by regulatory bodies (FDA, EMA, etc.) by providing required documentation and demonstrating compliance.
• Manage local infrastructure (servers, networks, desktops, printers) and coordinate with central IT teams for enterprise-level support.
• Implement and monitor cybersecurity protocols in the plant environment.
• Coordinate the rollout of new IT systems and upgrades while ensuring minimal disruption to manufacturing operations.
• Maintain and update IT SOPs in compliance with GxP standards.
• Collaborate with vendors and third-party service providers for support and maintenance of plant systems.
• Train and support end-users on relevant IT systems and best practices.

Qualifications & Skills:

• Bachelor's degree in computer science, Information Technology, or related field.
• 3+ years of IT experience, with at least 2 years in a pharmaceutical manufacturing environment.
• Strong knowledge of GxP, 21 CFR Part 11, and other applicable regulatory requirements.
• Experience supporting or managing systems such as MES, LIMS, SCADA, or ERP in a GMP environment.
• Familiarity with ITIL processes and system validation life cycle (SDLC).
• Strong troubleshooting, analytical, and communication skills.
• Ability to manage projects and coordinate cross-functional teams.
• Experience with audit readiness and participation is a strong advantage.