Senior System Engineer

Function

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 & SkillsTechnical 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.

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