Resilience

Engineer VI – QC Applications

Resilience

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $90,000 - $153,750 per year

Tech Stack

ApacheMS SQL ServerSQL

About the role

  • Serve as senior LabVantage technical subject matter expert for project execution and system enhancements, responsible for configuration, deployment, validation, adoption, and troubleshooting of LabVantage modules
  • Lead and manage enhancement projects to expand or upgrade QC applications, including rollouts of new LabVantage modules and development of reports and labels
  • Partner with scientific business stakeholders (e.g., QC) to gather and document user requirements and create actionable application designs and implementation plans
  • Provide troubleshooting and guidance for LabVantage issues and complex configurations
  • Support system integrations and assist in architecting solutions to enable secure and reliable data flow across applications
  • Serve as system support for QC applications, managing user accounts, access rights, roles, and privileges
  • Ensure reliable, compliant operation of critical QC systems
  • Manage change controls, deviations, and related records in the electronic Quality Management System (eQMS) for QC system projects
  • Partner with Quality and CSV to ensure regulatory compliance
  • Own and execute GxP validation activities for projects and system enhancements
  • Develop and maintain validation and system lifecycle documentation (e.g., SRS, specifications, IQ/OQ/PQ testing, SOPs)
  • Maintain compliance and audit readiness of assigned systems, ensuring adherence to 21 CFR Part 11 and other regulatory standards

Requirements

  • Experience developing and maintaining LabVantage reports preferably using Jaspersoft Studio
  • Extensive experience maintaining LabVantage LIMS in biotech, pharma, or life sciences
  • Experience developing and maintaining label printing solutions, preferably in BarTender
  • Strong project leadership experience, including planning and managing multiple concurrent projects
  • Excellent communication skills, with the ability to translate technical concepts for non-technical stakeholders
  • Strong analytical and problem-solving skills, with the ability to independently diagnose and resolve complex system issues
  • Programming experience using SQL
  • Experience with LabVantage architecture, including JBOSS, Microsoft SQL Server, and/or Apache or other applicable program
  • Experience with GxP validation and understanding of regulatory requirements (e.g., GxP, 21 CFR Part 11)
  • Proven experience authoring and maintaining SOPs, validation protocols, and system lifecycle documents.
Benefits
  • robust total rewards program including an annual cash bonus program
  • 401(k) plan with a generous company match
  • healthcare (including medical, dental and vision)
  • family building benefits
  • life and disability insurance
  • paid vacation
  • paid holidays
  • other paid leaves of absence
  • tuition reimbursement
  • support for caregiving needs
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
LabVantageJaspersoft StudioBarTenderSQLGxP validation21 CFR Part 11IQ/OQ/PQ testingSOPssystem lifecycle documentationQC applications
Soft Skills
project leadershipcommunication skillsanalytical skillsproblem-solving skills