Principal/Sr. Lab Systems EngineerApply Now
Location: Canton, Massachusetts
Employment Type: Direct Hire
Principal Technical Lab Specialist
COMPANY: High-Growth Biopharma Company w/ 1,000 employees in Clinical Development Phase
- 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
- 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
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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