Lab System Support Specialist

Job Title

Top 3 must have's:

• Hands-on support experience across diverse laboratory computing systems, including robotic, imaging, and chromatography acquisition and analysis systems, as well as high-throughput label printers and barcode scanners.
• Disciplined ITIL-based approach to ticket documentation and knowledge management, with consistent, accurate note capture and active contribution to a shared knowledge base.
• Experience as a change owner in a regulated (GxP preferred) environment, with the ability to align stakeholders and follow strict change management protocols.

Job Description:

• 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)

• Build, Install, Configure, Manage, and Administer Lab/Manufacturing computer systems in a regulated GMP environment.

• Good understanding of Windows Desktop OS support tasks and ability to set up brand new systems.

• Knowledge of simple AD account management and network connectivity requirements

• System imaging software experience and ability to learn new in-house methods.

• Providing direct support to end-users ranging from Tier 1 - 2 type issues.

• Remote support for a third location (Boston)

• Vendor support and account provisioning

• Work with vendor's tech support teams to resolve application errors as needed.

Command of IT ticketing system use, with timely work note updated and effective workload management.

• Dedicated support for the robotics PCD automation initiative - fault finding, coordination for new equipment setup, equipment moves

• Respond to IT support requests to address operational issues with enterprise and quality applications.

• Meet with internal clients and stakeholders to diagnose software and middleware issues.

• Proactively monitor and identify 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.

• In depth knowledge of Microsoft O365 applications and other productivity applications such as Adobe Acrobat

Ideal candidates will have experience with:

• Collaborating across business groups and sites to ensure global consistency.
• Continue to develop an understanding of the business processes and all applicable procedures.
• Contribute to timely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance
• Oversee and support managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systems.
• 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.
• Review/develop SOPs related to administration and installation of applications used in the lab/manufacturing environments.
• Enterprise system administration and monitoring tools such as Tanium, Eracent, Acronis, ServiceNow, BeyondTrust