JVT Advisors

Principal/Sr. Lab Systems Engineer

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Location: Canton, Massachusetts
Employment Type: Direct Hire

Job Description

Principal Technical Lab Specialist   

COMPANY: High-Growth Biopharma Company w/ 1,000 employees  in Clinical Development Phase

RESPONSIBILITIES

  • Responsible for maintaining, implementing enhancements, and validating laboratory instrumentation of the newly built Analytical Development and Quality Control Laboratory (GMP regulated)
  • Cross functionally coordinate all activities related to the delivery of bench-top laboratory systems
  • Troubleshoot interfaces and operation of laboratory systems such as Chromeleon
  • Spearhead lab systems projects including, configuration/design specifications, technical qualification protocols and validations plans
  • Help develop processes and procedures to ensure the efficient and compliant technical operations of GMP systems
  • Root cause analysis and triage support to resolve technical issues related to the lab systems
  • Help deploy new testing methods and test tooling  

QUALIFICATIONS

  • Bachelor of Science and minimum 6-8 years of experience in a regulated biotech or Pharma company
  • Ability to manage key deliverables on multiple projects in a fast-paced environment.
  • Assist with the creation of GMP computer system deliverables including user requirements, system specifications and validation test scripts
  • Ability to configure / troubleshoot / deploy / validate laboratory systems such as:  Chromeleon, LabVantage, LogiLab Scientific Data Management System (SDMS)
  • Working knowledge of relevant FDA, EU, ICH guidelines and regulations related to computer system validation and data integrity
  • Collaborate in a dynamic, cross-functional matrix environment

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Blain Poulin

Senior Recruiter

Blain is a full-desk recruiter on the Direct-Hire team, responsible for recruiting for a wide variety of IT jobs. He is focused on professional services, network/systems, and cyber security, with a special interest in DevOps.

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