System Engineer - Abzena

System Engineer

Location: Bristol, PA
Area: Information Technology

This role is primarily focused on supporting staff in the Bristol, PA office with day-to-day IT issues and upgrades. There is also a requirement for the role to proactively monitor the state of the systems and security, and to generate proposals to remedy any issues found.  The role will be performed in the clinical trials industry in accordance with FDA and ICH guidelines.


Main Responsibilities:  

  • Installing and configuring computer hardware operating systems and applications for business operations
  • Supporting computer systems and other on-site hardware
  • Maintaining a comprehensive inventory of all computer and laboratory equipment
  • Talking staff or clients through a series of actions, either face-to-face or over the telephone, to help set up systems or resolve issues
  • Troubleshooting system or network problems, diagnosing and solving hardware or software faults
  • Replacing computer system and/or network components as required
  • Providing support, including procedural documentation and relevant reports
  • Supporting the roll-out of new applications
  • Responding within agreed time limits to tickets
  • Prioritizing and managing many open cases at one time
  • Rapidly establishing a good working relationship with users and suppliers


Other Responsibilities:

  • Testing and evaluating new technology
  • Attending weekly IT conference calls with global IT team
  • Proactively anticipate issues and make recommendations
  • Carry out any other duties that are reasonably asked of you


Person Specification Essential skills:

  • Excellent customer service skills
  • Self-motivated, able to work unsupervised
  • At least three (3) years experience in a similar role
  • Solid track record within IT support roles
  • Understanding of IT security best practices
  • Strong written and verbal communication skills
  • Knowledge of VoIP Telephony Systems (Skype)
  • Experienced with Microsoft 365
  • Clear understanding of IT infrastructure equipment
  • Working knowledge of the following clinical trial industry guidelines:
    • FDA 21 CFR Part 11
    • FDA Guidance: Computerized Systems Used in Clinical Investigations


Desirable skills:  

  • Knowledge of ITIL principles
  • Ability to recommended procedure modifications or improvements
  • Knowledge of Microsoft TEAMS
  • Experience of working in a Good Manufacturing Practice environment
  • Familiar with FDA and ICH Good Clinical Practice and/or Good Manufacturing Practice
  • Familiar with FDA Guidance: General Principles of Software Validation
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