Top 3 must have's:
o 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.
o Disciplined ITIL-based approach to ticket documentation and knowledge management, with consistent, accurate note capture and active contribution to a shared knowledge base.
o Experience as a change owner in a regulated (GxP preferred) environment, with the ability to align stakeholders and follow strict change management protocols.
JD:
• 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.
o Good understanding of Windows Desktop OS support tasks and ability to set up brand new systems.
o Knowledge of simple AD account management and network connectivity requirements
o 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.
o Remote support for a third location (Boston)
o Vendor support and account provisioning
o 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.
o Dedicated support for the robotics PCD automation initiative - fault finding, coordination for new equipment setup, equipment moves
o Respond to IT support requests to address operational issues with enterprise and quality applications.
o Meet with internal clients and stakeholders to diagnose software and middleware issues.
o Proactively monitor and identifY trends and behaviors in systems support and address the findings or escalate to other IT team resources.
o 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.
o Continue to develop an understanding of the business processes and all applicable procedures.
o Contribute to timely and accurate communications with other parts of the organization regarding IT projects, timelines, and compliance
o Oversee and support managed services staff with the installation/configuration of regulated Lab/Manufacturing GMP systems.
o Serve as the System Owner/Manager and perform administrative tasks on QC/Manufacturing instruments/systems such as user additions, removal, method/assay updates.
o 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
o Participate in process re-engineering workshops with business and IT stakeholders.
o Perform impact assessment on changing product capabilities, including impact to integrated (boundary) systems.
o 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