Job Title: IT Administrator Position Summary We are seeking a highly skilled and proactive IT Administrator to join our in-house IT team. The IT Administrator will be responsible for managing, maintaining, and supporting our organization's technology infrastructure, with a specialized focus on the IT systems critical to the drug development and manufacturing process. This role is crucial for ensuring secure, efficient, and compliant IT operations across our CDMO (Contract Development and Manufacturing Organization) environment.
Key Responsibilities General IT Operations - Manage network infrastructure and ensure stable connectivity, network security, and performance.
- Administer and maintain servers, workstations, operating systems, and enterprise applications.
- Provide end-user technical support including software installation, troubleshooting, and password management.
- Maintain hardware inventory, coordinate equipment repair and replacement.
Cybersecurity & Compliance - Implement and manage cybersecurity protocols to safeguard sensitive information.
- Ensure compliance with FDA 21 CFR Part 11 and other relevant regulatory standards.
- Maintain audit trails, electronic signatures, and secure data storage practices.
System & Software Management - Oversee the deployment, maintenance, and upgrades of business-critical software including ERP, SCADA, SAP systems.
- Manage backup and disaster recovery procedures to prevent data loss and ensure business continuity.
CDMO-Specific IT Support - Support data management systems for drug development, quality control, and clinical trials.
- Maintain Manufacturing Execution Systems (MES) for real-time production monitoring and control.
- Support Laboratory Information Management Systems (LIMS) for test tracking and quality data management.
- Collaborate with QA to develop IT solutions for document control, deviation tracking, and quality metrics reporting.
Stakeholder Collaboration & Project Management - Coordinate with internal departments (QA, Manufacturing, Regulatory, etc.) and external partners (CROs, CDMOs).
- Lead and execute IT-related projects such as system implementations, upgrades, or infrastructure expansion.
- Develop user training materials and promote best IT practices within the company.
Qualifications - Bachelor's degree in Information Technology, Computer Science, or related field
- 1+ years of IT administration experience, preferably in the pharmaceutical or biotechnology sector.
- Familiarity with GMP regulations, MES, LIMS, ERP systems (e.g., SAP), and data compliance frameworks.
- Strong problem-solving skills and the ability to manage multiple priorities.
- Excellent communication and teamwork skills.
- Bilingual - Mandarin & English preferred
Preferred Skills - Experience working within a CDMO environment.
- Knowledge of pharmaceutical manufacturing processes.
- Familiarity with regulatory submission and reporting systems.