It Support (Gxp/Pharmaceutical)

Local Site Infrastructure Technician

San Diego, CA

Role purpose:

1. Become visible and provide IT support to the customer and provide guidance and support as needed.
2. Have solid understanding of working in a fast-paced environment, supporting onsite clients as well as home office users.
3. Off hour, Weekend and Holiday support for all operational assets and systems as needed.

Main responsibilities:

• Inventory control and asset management
• Adhere to scheduled appointments for asset recovery collections and e-waste processes.
• Ensure OT environment health: maintain the landscape, network documents and integration with IT solutions
• Support Users Remotely utilizing teams, Bomgar or Remote desktop.
• Strong relationship with global solution groups
• Ability to troubleshoot (hardware, software and connectivity) incidents through to resolution

Key Responsibilities

• Create build records. Ensure GDP standards, sign and send to lab teams.
• Provide guidance to clients and Support projects in progress in collaboration with other IT organizations. Interface and collaborate with other teams for issue resolutions.
• Clean and prepare all hardware for reuse, which includes, running diagnostics and submitting OEM tickets for repair.
• Supports, manages, optimizes, and maintains the configuration and installation of the Servers, to include, but not limited to, patch updates, hardware replacements, with spares.
• Create automatic backups of lab images and account access logs
• Track logistics of equipment, transferring between stock rooms (both physically & logically) with attention to detail. Following litigation processes to ensure all equipment is quarantined properly.
• Experience working in a team-oriented, collaborative environment with strong customer-service orientation.
• Engage with Quality Control representatives to ensure solutions are delivered and maintained to meet business goals and end user needs.
• Review and approve qualification documents.
• Coordinate, prioritize, and manage the QCIT deliverables for new system implementation.
• Other Ad Hoc Activities and Reporting as required• Update, review, and approve SOPs.
• Work with vendors on troubleshooting and implementation of lab devices.
• Coordinate and manage the deliverables of monthly maintenance events.
• Assist Manufacturing / Engineering personnel with remediation of machine and software accounts.
• Manage and maintain relevant SOPs and other documentation e.g., Knowledge Base articles following GxP, GmP and GDP practices.
• Track all incoming/outgoing activities via client's asset management system. Maintain Excel/SharePoint Trackers on all equipment, as well as in client's asset management system.
• Meet with vendors pre-implementation of new technology and ensure Client IT standards are met.
• Use knowledge of technology to implement new automation and quality of life for engineering / manufacturing personnel.
• Engage with Quality Control (QC) representatives to ensure solutions are delivered and maintained to meet business goals and end user needs.
• Ensure all quality standards are met to comply with FDA, EMA and CDC standards.
• Utilize COMAP to ensure only proper patching is sent to devices based off vendor and software needs.
• Perform IQ and OQ activities where needed.
• Self-motivated and directed, with the ability to effectively prioritize and execute tasks in a high-pressure environment.
• Analyze Client Service calls for desktop devices and incident data to identify and advise Client of any potential user-training requirement and automation and to drive continuous service improvements.

Technical Skills:

• Understanding of Office Suite and SharePoint Technologies
• Must have valid license.
• Knowledge of software distribution, patching and imaging technologies desirable
• Good understanding of network infrastructure of DNS, Proxy servers and firewalls
• Hands-on hardware troubleshooting experience
• Experienced in Service Now ticketing system
• Ability to lift 50lbs.
• Knowledge of Active Directory, SCCM or other User and Asset rights or deployment systems
• Solid knowledge of Windows, IOS or other computer operating systems
• Ability to read and understand technical manuals, procedural documentation and OEM guides
• Understand and follow GxP, GmP, and GDP practices
• Good knowledge of LAN/WAN setups and concepts
• Must have solid soft skills and be a good communicator.
• Knowledge of IMAC, SLA's and Asset management, ITIL

Preferred Qualifications:

Associate degree in an IT-related field or working experience

• Experienced with GxP compliance and Computer Systems Validation
• At least 2 years of working experience in information technology. Excellent knowledge of English language (written and spoken).
• Strong knowledge of laboratory instruments and related software applications
• Experienced with troubleshooting and problem-solving
• Working understanding of IT infrastructure and architecture. Knowledge of pharma processes preferred