IT / OT Systems Analyst (Pharmaceutical Manufacturing)

5 days ago


Singapore ALWAYSHIRED PTE. LTD. Full time
Roles & Responsibilities

Location: West area

We are looking for an IT/OT Systems Analyst to support our pharmaceutical manufacturing operations. This role will be responsible for managing and troubleshooting IT and OT systems on the shopfloor, ensuring system availability, compliance, and security. The ideal candidate will have a strong understanding of IT infrastructure, operational technology (OT), and regulatory requirements in a GMP-regulated environment.

  • Provide first-level support to operations users and resolve issues related to manufacturing and lab systems.
  • Execute crisis management plans (e.g., PIAB, BCP) for critical manufacturing and lab systems and assist in coordinating major system downtimes.
  • Manage user access, perform recertifications, conduct audit trail reviews, and oversee backup/restore and data archival processes.
  • Ensure systems comply with GMP, FDA 21 CFR Part 11, and cybersecurity requirements. Participate in investigations related to security non-compliance and propose corrective/preventive actions.
  • Execute small-scale IT/OT projects, develop test cases, perform system qualification, and provide post-change support.
  • Oversee systems patching, downtime activities, and shopfloor qualifications.
  • Collaborate with operations, quality, and IT teams to enhance system performance and ensure alignment with manufacturing needs.

Requirement:

  • Bachelor's degree or higher in Computer Science, Information Technology, Engineering, or a related field.
  • 3-5 years of experience in IT/OT support within pharmaceutical, biotech, or manufacturing industries.
  • Hands-on experience with manufacturing & enterprise systems (e.g., PI, MES, LIMS).
  • Understanding of Good Manufacturing Practices (GMP), regulatory compliance (FDA 21 CFR Part 11, GAMP 5), and cybersecurity principles.
  • Strong knowledge of IT infrastructure, system administration, and troubleshooting OT systems.
  • Experience with incident management, disaster recovery (BCP, PIAB), and change control processes.
  • Familiarity with system validation, qualification, and compliance in regulated environments.
  • Effective communication and stakeholder management skills.Ability to work in a fast-paced, regulated manufacturing environment.

Interested candidates please apply online or send your latest CV to alex.fong@AlwaysHired.com.sg

AlwaysHired Pte Ltd

Reg No: R1549345

EA: 24C2293

We regret to inform that only shortlisted candidates will be notified. Please note that your response to this advertisement will constitute informed consent to the collection, use, and/or disclosure of personal data by AlwaysHired, its affiliates and, where necessary, to relevant third parties, for purposes such as job application processing, career advisory, research, and other administrative purposes, in compliance

Tell employers what skills you have

MES
FDA
Regulatory Compliance
GMP
GAMP
Test Cases
Manufacturing Operations
LIMS
System Administration
Change Control
Crisis Management
Regulatory Requirements
Disaster Recovery
Incident Management

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