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Laboratory Systems Sr. Engineer


Location: Norwood , Massachusetts
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POSITION DESCRIPTION

 

The Role:

Reporting to the Director of QMS and Lab Systems, the Laboratory Systems Sr. Engineer will support the technical delivery and routine maintenance of lab software systems including the Scientific Data Management system, Chromeleon and other bench-top validated software solutions. The role will help design creative solutions in an integrated laboratory environment while assisting with second-tier advanced troubleshooting in a GMP environment.  

 

Here’s What You’ll Do:

  • Develop new system capabilities and deploy integrated instruments using LogiLab Scientific Data Management Systems (SDMS).
  • Develop parsing scripts to pull data into LabVantage LIMS from the SDMS system.
  • Understand and map instrument data flows across all laboratory systems.
  • Provide second-tier support to troubleshoot interfaces and operation of laboratory systems such as Chromeleon, SDMS and other bench-top computerized GxP systems.
  • Develop deliverables to support lab systems projects including, configuration/design specifications, system administration SOP’s, technical qualification protocols and validations plans.
  • Ensure continuous laboratory data integrity and identify any data integrity issues.
  • Assist with the development of processes and procedures to ensure the efficient and compliant technical operations of GMP systems.
  • Provide administrative support to operate QC labs systems including role management, access management and configuration maintenance.
  • Provide complex root cause analysis and triage support to resolve technical issues related to the operations of lab systems.
  • Assist with the deployment of new testing methodologies and tools to streamline testing.
  • Understand change control, deviation and CAPA process. Prior experience of working in Veeva Docs and QMS a plus.

Here’s What You’ll Bring to the Table:

  • Bachelors of Science and minimum 6-8 years of experience in a regulated biotech or Pharma company.
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer system validation and data integrity.
  • Strong communication skills (verbal and written).
  • Ability to manage key deliverables on multiple projects in a fast-paced environment.
  • Ability to effectively collaborate effectively in a dynamic, cross-functional matrix environment.

 


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