IT Systems Manager (Clayton) Job at Insight Global, Clayton, NC

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  • Insight Global
  • Clayton, NC

Job Description

Qualifications:

  • Bachelors Degree in Engineering, Computer Science, or related field.
  • Minimum 5+ years in IT systems management within a cGMP pharmaceutical environment.
  • Proven expertise in computer system validation (CSV), data integrity, and compliance frameworks.
  • Strong knowledge of IT security principles and regulatory guidelines.
  • Ability to lead cross-functional teams and manage complex technical environments.
  • Knowledge of industrial control systems, automation platforms (e.g., DeltaV, Syncade).
  • Experience with aseptic production systems preferred.

Job Description:

Insight Global is seeking an IT Systems Manager for a pharmaceutical client in the Raleigh area. The IT Systems Manager will lead and manage GxP-compliant IT systems and computerized equipment supporting aseptic and finished production environments. This role ensures operational excellence, regulatory compliance, and secure system performance across critical pharmaceutical manufacturing processes.

Key Responsibilities

  • Oversee delivery of lifecycle project work packages for IT systems and computerized equipment in production facilities.
  • Implement and maintain GxP compliance through risk-based validation processes (ASTM E2500, GAMP 5).
  • Conduct data integrity and IT security risk assessments; develop and implement mitigation strategies.
  • Manage operation and maintenance of industrial control systems, ensuring secure and reliable performance.
  • Lead change control processes and maintain accurate system documentation.
  • Provide coaching and mentoring to technical staff; foster a culture of quality and compliance.
  • Perform periodic reviews, audit trail analysis, and ensure adherence to regulatory standards (EMA, MHRA, OECD-17, PIC/S).
  • Develop disaster recovery and backup strategies to safeguard critical systems.

Job Tags

Part time,

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