Job Description

Senior IT Systems Specialist
Job Number: 21-15727

 
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Senior IT Systems Specialist for our client in Lexington, MA. 
 
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
 
 
Position Overview:

  • Must have implemented Cell Counters and Chemistry Analyzers (or other similar systems) in a GMP environment following Analytical Instrument Qualification SOPs.
  • As a member of site IT team, you will collaborate with Business, IT, and vendors to implement various GxP & non-GxP computerized systems.

Responsibilities:
  • Intake computer system requirements (Hardware, OS, Active Directory, networking, firewall rules, security groups, backup/restore)
  • Author/update System Design and Config Spec (SDCS) and architecture diagrams
  • Initiate IT tickets in ServiceNow and builds computer system per company standards e.g. image the PC and add to Active Directory; Install anti-virus, backup/restore, and any pre-requisite software, enable remote management, kiosk mode etc.
  • Install drivers and verify connectivity to analytical instruments, peripheral devices, and/or printers
  • Coordinate between multiple IT teams including site and Global IT infrastructure teams for deploying and troubleshooting applications
  • Follow Takeda's SDLC, AIQ methodology, and documentation standards to author and execute IQ/OQ scripts for qualification of the computer system
  • Author System Administration SOPs and User Access Forms
 
Qualifications:
  • Bachelor's degree in information technology, computer science, engineering, or a related study (required)
  • Overall 7 years IT experience with at least 5 years laboratory system implementation & support in QC, Mfg Sciences, R&D, or Mfg (required).
  • Working knowledge and experience with following technologies (required):
    • Windows Hardware, Desktop & Server OS, SQL Database and scripts, Active Directory, Basic Networking, Backup\Restore, Citrix/RDS
    • Thick and thin client application architectures
    • Barcode scanners, printers (Zebra label, P-touch)
    • MS Outlook, Word, Excel, Visio, Teams, SharePoint, OneDrive
  • Familiarity with following GxP processes used in Pharmaceutical industry (required):
    • Computerized Systems Validation (CSV) or Analytical Instrument Qualification (AIQ)
    • 21 CFR Part 11 regulations and Data Integrity compliance
    • Familiarity with following tools and processes (preferred):
    • ServiceNow – ITIL processes such as Incident Management, Change Management, Request Management, Asset and Configuration Management (CMDB)
    • TrackWise QMS – CAPA, Deviation, Change Control
    • Client ALM / Kneat – Electronic Testing and Validation
    • Veeva EDMS – Document Workflows
 
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
 
If interested, you may contact:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
6466952942
Paul Quibuyen | LinkedIn
 
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
 
 

 

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