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GxP Systems Sr. Engineer

Date: Apr 6, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

Summary

 

Reporting to the IT Service Delivery Lead, the GxP Systems Engineer’s primary duties include integrating solutions of a secure, controlled computing environment for GxP systems that are connected to lab, manufacturing and QC systems and instruments to ensure regulatory compliance.

The position requires a deep understanding of GxP system processes, end point computing and automation, end-point security tools, and automation of computer system administration tasks.  The candidate will gather requirements from the business, design sound solutions with the assistance of the IT Service Delivery Lead.  The candidate will also Collaborate with scientists, instrument vendors, Validation groups and IT colleagues to troubleshoot and support systems in a controlled Manufacturing and Quality Control environment.  They will also interface with the IT Infrastructure and Security teams for network, backup, disaster recovery, cybersecurity protection and monitoring needs.

 

Responsibilities

 

Ensuring the initial installation and configuration of the system for CFR Part 11 and desktop security within the Spark IT computer network. This includes working with the vendor to determine infrastructure design requirements, workstation IDs, security patches, hard drive partitions, network settings, GPO settings, password settings and configuration, backup configuration, ensure this information is encoded into the computer systems and locked so that it cannot be altered by regular users and other technical elements.

Partner with Computer Systems Validation (CSV), business owners and Business Analysts to determine best long-term solutions for a compliant IT landscape

Partner with CSV and business owners and Business Analysts to evaluate technical possibilities

3rd level desktop IT support for the GxP landscape

 

 

Education and Experience Requirements 

 

 

Bachelor’s Degree in Computer Science, Business, IT or related field or equivalent experience

5 years of hands on IT support experience at a life science organization, with at least 2 years supporting GxP lab applications and systems.

3 years of intensive hands on experience with the Windows OS operating environment, including:

  • Microsoft Windows patch management, WSUS, etc.
  • USMT and Operating System deployment tools
  • Desktop security, folder permissions, groups, registry
  • Strong knowledge of PowerShell scripting

Expert knowledge of Active Directory, schema modifications, domain creation and management

Understanding of GAMP 5, 21 CFR part 11, and Computer System Validation

Knowledge of laboratory automation technologies such as electronic laboratory notebooks, lab or manufacturing execution systems, LIMS, chromatography systems, scientific data management systems, etc.

 

 

Key Skills and Abilities 

 

Excellent collaboration and communication skills, the ability to manage competing priorities and flexibility to shift workload when needed.

Self-motivation and the ability to multi-task and balance multiple goals and priorities

Ability to work in a team environment; strong interpersonal skills and adaptability are a must

 Ability to maintain open and constant communication with internal employees, contractors, customers, managers, and others as needed

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Nearest Major Market: Philadelphia