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.