Junior IT Support Specialist – Pharmaceutical Manufacturing

1 week ago


Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time
Roles & Responsibilities

We are seeking a Junior IT Support Specialist to join our pharmaceutical manufacturing IT team. The ideal candidate will have 1–2 years of experience in IT support and a foundational understanding of Software Development Life Cycle (SDLC) and/orComputer System Validation (CSV). This role involves providing technical support for IT manufacturing systems and managing the manufacturing-controlled networkto ensure seamless operations in a regulated environment.

Key Responsibilities

Manufacturing Systems Support:

  • Assist in the configuration, maintenance, and troubleshooting of systems such as OSI PI, MES, Lab Systems.
  • Provide first-level support for systems related issues and escalate complex problems when necessary

Manufacturing-Controlled Network Management:

  • Support the operation and maintenance of IT infrastructure within the manufacturing environment.
  • Ensure compliance with Good Automated Manufacturing Practice (GAMP) and GxP regulations.
  • Assist in the management of network connectivity for manufacturing systems, ensuring data integrity and security.

Software Development Life Cycle (SDLC) & Computer System Validation (CSV):

  • Support the implementation and validation of IT systems in compliance with regulatory requirements.
  • Assist in drafting and maintaining validation documentation, including user requirements and test scripts.
  • Ensure adherence to SDLC best practices in pharmaceutical manufacturing environments.

Technical Support & Troubleshooting:

  • Provide Level 1 and Level 2 IT support for manufacturing and production-related IT systems.
  • Collaborate with cross-functional teams, including engineering, quality assurance, and production staff.
  • Conduct root cause analysis for IT-related issues and recommend solutions to minimize downtime.

Compliance & Documentation:

  • Maintain accurate records of IT activities, including system configurations, updates, and troubleshooting logs.
  • Assist in ensuring IT systems comply with FDA 21 CFR Part 11 and other industry regulations.
  • Follow change control procedures and support audits related to IT systems.

Required Qualifications & Skills

  • Experience: 1–2 years in IT support, preferably in a pharmaceutical or regulated manufacturing environment.
  • Familiarity with manufacturing IT systems and networks.
    • Knowledge of Software Development Life Cycle (SDLC) and Computer System Validation (CSV).
  • Regulatory & Compliance Understanding: Exposure to GxP, GMP, or FDA compliance requirements is a plus.
  • Problem-Solving Skills: Ability to troubleshoot IT issues and support critical manufacturing processes.
  • Communication & Collaboration: Strong interpersonal skills to work with cross-functional teams.
  • Knowledge of virtualization technologies, industrial control networks, or cybersecurity best practices in manufacturing is a plus.
Tell employers what skills you have

MES
GxP
Network Management
Troubleshooting
FDA
Manufacturing Processes
GMP
GAMP
SDLC
Computer System Validation
Change Control
Manufacturing
Virtualization
Software Development
Technical Support

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