Role Overview:
Responsible for managing the lifecycle of computerized lab systems, including projects and ongoing support. Focus is on ensuring secure, reliable, and compliant lab systems throughout their lifecycle.
Key Responsibilities:
* Manage the full lifecycle of computerized systems used in QC, MSAT labs, and manufacturing plants.
* Develop, implement, and maintain architecture and design specifications, as well as installation instructions, with emphasis on new system implementations.
* Evaluate system performance, suggest improvements, and implement enhancements.
* Research and eliminate process bottlenecks; apply best practices in collaboration with system vendors, business experts (QC, MSAT, Manufacturing), and QA/validation teams.
* Contribute to validation and maintenance activities for GxP lab applications.
* Act as Level 3 expert and provide on-site support when needed.
* Ensure backup, restore, and disaster recovery plans are maintained and periodically tested for all systems.
Required Experience & Skills
Technical Expertise:
* Microsoft operating systems: Windows 7, 10, 11; Server 2012, 2016, 2022, 2025 (MCSE certification is a plus).
* Networking fundamentals: TCP/IP, antivirus, remote administration, Active Directory, and general IT infrastructure.
* Scripting skills: DOS command line, VBScript, PowerShell.
* Strong documentation skills: ability to produce detailed, complete, and accurate specifications and instructions.
Regulatory & Methodology Knowledge:
* Validation and qualification methodology.
* GMP compliance requirements.
Experience:
* Previous experience in a similar role is highly preferred.
* Ability to work independently and collaboratively within a team environment.