Role Overview
We are looking for a detail-oriented and proactive IT Support Engineer to maintain the reliability, security, and compliance of IT systems in our pharmaceutical manufacturing operations. This role is crucial in supporting Computer System Validation (CSV), ensuring data integrity, and maintaining GxP compliance across all IT-related systems. Key
Responsibilities
- Provide daily technical support for IT systems in manufacturing and laboratory environments.
- Perform Computer System Validation (CSV) activities in line with FDA, GMP, and other regulatory standards.
- Ensure accurate time synchronization across all systems and devices.
- Plan, execute, and verify data, program, and image backups/restoration (monthly, yearly, or as needed).
- Manage and maintain Role-Based Access Control (RBAC) for different user levels (Operator, Supervisor, Maintenance, Engineering, Admin).
- Perform Operating System (OS) hardening by applying security patches, disabling unnecessary services, and enhancing system protection.
- Support and document periodic CSV reviews (annual system performance, security, and compliance checks).
- Assist in audits, investigations, data retrieval, and documentation for regulatory inspections.
- Collaborate with Quality, Engineering, and Operations teams to support Change Control, CAPA, and Deviation Management.
- Ensure all IT-related activities comply with SOPs, QMS policies, and regulatory audit requirements.
Qualifications & Requirements
- Diploma or Bachelor’s Degree in Information Technology, Computer Science, or related field.
- Minimum 2–4 years of experience in IT support (preferably in a regulated or manufacturing environment).
- Knowledge of GxP, CSV, and data integrity principles.
- Strong understanding of Windows OS administration, networking, and system security.
- Excellent troubleshooting, documentation, and communication skills.
- Ability to work independently and collaboratively within cross-functional teams.
Pay: RM3,500.00 - RM5,500.00 per month
Application Question(s):
- How many years of experience do you have in IT Support?
- Are you willing to work in Gelang Patah?
- do you have any Knowledge of GxP, CSV, and data integrity principles.
Work Location: In person