Lab System Support Specialist

TechDigital Group; San Francisco (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

A technology support company in San Francisco is looking for an IT Support Specialist to provide assistance with end-user issues, manage system configurations, and support various IT initiatives. The ideal candidate will have deep knowledge of GxP operations, expertise in Windows Desktop OS, and experience with system imaging and network troubleshooting. This role involves both direct support and collaboration with internal stakeholders to align IT processes with business needs.

Qualifications

• In-depth knowledge of FDA's CFR 21 Part 11 requirements.
• Hands-on experience with PC builds and vendor support.
• Ability to follow troubleshooting steps and document findings.

Responsibilities

• Provide direct support to end-users for IT issues.
• Develop understanding of business processes and procedures.
• Install and configure computer systems in regulated environments.

Skills

GxP operations

Windows Desktop OS support

System imaging software

Microsoft O365 applications

AD account management

Tools

Lab/Manufacturing computer systems

Job description

Top 3 must have's

• Experience with - Build PCs
• Vendor support and account provisioning
• Dedicated support for the robotics PCD automation initiative - fault finding, coordination for new equipment setup, equipment moves

Job description

• Providing direct support to end-users ranging from Tier 1 - 2 type issues.
• Continue to develop an understanding of the business processes and all applicable procedures.
• Build PCs
• Vendor support and account provisioning
• Dedicated support for the robotics PCD automation initiative - fault finding, coordination for new equipment setup , equipment moves
• Remote support for a third location (Boston)
• In-depth knowledge of GxP operations as it relates to the FDA's CFR 21 Part 11 requirements and well as Good Documentation Practices (GDP)
• Good understanding of Windows Desktop OS support tasks (7 – Win 10) and ability to set up brand new systems.
• Install and configure Lab/Manufacturing computer systems in a regulated GMP environment.
• Oversee and support managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systems.
• Work with vendor's tech support teams to resolve application errors as needed.
• Serve as the System Owner/Manager and perform administrative tasks on QC/Manufacturing instruments/systems such as user additions, removal, method/assay updates.
• Partner with local QA/QE to evaluate and test new upgrades/patches to Operating Systems/applications and write install instruction for Lab/MFG managed services support personnel.
• Participate in process re-engineering workshops with business and IT stakeholders.
• Perform impact assessment on changing product capabilities, including impact to integrated (boundary) systems.
• Respond to IT support requests to address operational issues with enterprise andquality applications.
• Meet with internal clients and stakeholders to diagnose software and middleware issues.
• Align with other manufacturing sites and corporate IT to ensure global consistency.
• Review/develop SOPs related to administration and installation of applications used in the lab/manufacturing environments.
• Troubleshooting and replacement of hardware component and systems
• System imaging software experience and ability to learn new in-house methods.
• Knowledge of simple AD account management and network connectivity requirements
• Able to trace phone and network patch cables to wall jacks with the aid of network testing devices.
• In depth knowledge of Microsoft O365 applications and other productivity applications such as Adobe Acrobat
• Command of IT ticketing system use and effective workload management.
• Proactively monitors and identifies trends and behaviors in systems support and address the findings or escalate to other IT team resources.
• Able to follow other specific troubleshooting steps and continuously update and create additional knowledge articles.
• Contributing to timely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance