GMP Senior/Principal IT Engineer

I. Position Summary

This role is responsible for the full lifecycle management of the company's global GMP-related IT systems supporting QC. Acting as the technical bridge between IT and QC, the role ensures system stability and compliance within a local data center and private cloud environment. The engineer must balance GMP compliance requirements with global multi-timezone business continuity, and possess code-level troubleshooting capabilities as well as experience with digital productivity tools.

II. Core Responsibilities

1. GMP IT System Lifecycle Management

· Act as the IT Owner or key technical lead for systems supporting QC.

· Responsible for system high-level design, technology selection, version upgrades, and retirement management.

· Establish and maintain the compliance baseline for system operations (including configuration, access control, audit trail, time synchronization, backup and recovery).

· Participate in IT technical investigations of system-related deviations or changes, providing technical root cause analysis and corrective action plans.

2. In-Depth Troubleshooting of System and Interface Failures

· Possess coding capability to deeply investigate system failures (e.g., service crashes, performance degradation, data inconsistencies).

· Troubleshoot interface failures (e.g., between LIMS and MES), including:

o Analyzing interface logs, error stacks, and data payloads.

o Identifying whether the issue resides in a specific system, service, or code logic.

o Distinguishing between configuration issues, data problems, network faults, or code defects.

· Write or modify small scripts/tools for failure reproduction, log analysis, data validation, or automated remediation.

3. Application of Digital Productivity Tools

· Identify opportunities for digital efficiency improvements within GMP business processes (e.g., approval workflow automation, automated report generation, data reconciliation).

· Utilize tools such as Power Automate, RPA, and low-code platforms to achieve process automation within a compliant framework.

· Possess a basic understanding of AI/machine learning application scenarios in GMP environments (e.g., audit trail anomaly detection, predictive maintenance).

4. Multi-Timezone Global Operations and Emergency Response

· Support operations across multiple time zones (e.g., Europe, China, United States).

· Balance business recovery and compliance records during emergency situations.

· Manage change control windows, patching cycles, and system maintenance plans across time zones.

5. IT Architecture and Infrastructure

· Participate in the design of IT architecture for GMP systems (servers, VMware virtualization, storage, network segmentation, firewall policies).

· Manage system deployment, data synchronization, and disaster recovery strategies between the local data center and private cloud platforms.

· Identify and mitigate GMP risks at the IT infrastructure level.

6. CSV/CSA and Regulatory Compliance

· Lead or participate in computerized system validation activities (risk assessment, validation strategy, documentation review).

· Ensure systems comply with EU GMP Annex 11, 21 CFR Part 11, data integrity (ALCOA+), and NMPA requirements.

· Support global regulatory inspections (FDA, EMA, NMPA, etc.), handling IT-related audit support and CAPA execution.

7. Cross-Functional and Vendor Collaboration

· Serve as the technical interface between IT and QC.

· Manage global system vendors and integrators, driving them to resolve interface and system defects.

III. Qualifications

Education

· Bachelor's degree or higher in Computer Science, Information Systems, Software Engineering, Automation, Data Science, or a related field.

Work Experience

· 5+ years of IT-related experience, with at least 3 years in a GMP/GxP environment.

· Experience in pharmaceutical, biopharmaceutical or vaccine industries is preferred.

· Experience supporting global multi-site or multi-time zone operations is preferred.

· Experience in LIMS or ELN is preferred.

Required Skills

Code and Troubleshooting Ability

· Proficient in at least one programming/scripting language (e.g., Python, PowerShell, C#, Java, JavaScript), with the ability to:

o Read and understand existing code/script logic.

o Write small tools for log analysis, data validation, interface testing, and automated remediation.

o Identify code-level root causes for system and interface failures.

· Familiar with common interface protocols (RESTful API, SOAP, message queues, direct database connections, etc.).

· Able to analyze interface logs, error stacks, and network packet captures to determine issue ownership.

Digital Productivity Tool Experience

· Hands-on experience with Power Automate, RPA (e.g., UiPath), low-code platforms, etc.

· Capable of designing and deploying automated processes within GMP compliance constraints.

· Basic understanding of AI/LLM applications in GMP scenarios.

GMP and Compliance

· Deep understanding of how GMP regulations apply to IT systems.

· Familiar with computerized system validation (CSV or CSA).

· Mastery of key data integrity control points (audit trail, access control, time synchronization, backup/restore).

IT Technical Capabilities

· Windows/Linux Server administration.

· Virtualization platforms.

· Databases (SQL Server/Oracle), with ability to write complex queries, analyze execution plans, and identify performance bottlenecks.

· Networking fundamentals (VLAN, firewall, NTP, DNS).

· Storage and backup principles.

Risk Judgment

· Able to independently assess the GMP impact level of an IT action (e.g., service restart, configuration change, temporary workaround).

· Capable of making decisions that are "operationally recoverable and compliantly explainable" under emergency situations.

Soft Skills

· Strong sense of responsibility and respect for compliance.

· Ability to explain technical issues to business in non-IT language.

· Cross-time-zone collaboration capability (written English plus verbal communication).

· Solves problems systematically rather than applying superficial fixes.

AI-Related Experience

· Understanding or hands-on experience with AI application scenarios in GMP environments (e.g., audit trail anomaly detection, predictive maintenance, LLM-assisted documentation processing).

· Experience collaborating with data science teams to deploy AI models in regulated environments.

IV. Nice-to-Have

· Experience as a System Owner, or participation in official FDA/EMA/NMPA inspections with on-site response.

· Experience deploying or operating GMP systems in a hybrid cloud environment.

· Familiarity with ITIL (Incident, Change, Problem, Configuration Management).