Laboratory Systems Sr. Engineer

  • location: Norwood, MA
  • type: Contract
  • salary: $75 - $85 per hour

job description

Laboratory Systems Sr. Engineer

job summary:
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.

 
location: Norwood, Massachusetts
job type: Contract
salary: $75 - 85 per hour
work hours: 8am to 4pm
education: Bachelors
 
responsibilities:
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

 
qualifications:
  • Experience level: Experienced
  • Minimum 5 years of experience
  • Education: Bachelors
 
skills:
  • Desktop Support (5 years of experience is preferred)
  • lab support (4 years of experience is preferred)

Equal Opportunity Employer: 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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