Senior Scientist, Laboratory Automation & Instrumentation Engineer - Quality Control

BioMérieux

  • Durham, NC
  • Permanent
  • Full-time
  • 7 hours ago
DescriptionThe Senior Scientist, Laboratory Automation & Instrumentation Engineer is the site's recognized subject matter expert in laboratory automation, instrumentation, and system integration. This senior scientist is an individual contributor SME for the design, implementation, optimization, and lifecycle management of automated platforms and laboratory instruments across Quality Control (QC) and related operations at sister sites. The role combines advanced technical expertise with strategic vision to enhance operational efficiency, data integrity, and regulatory compliance.Working in partnership with R & D scientists, engineers, IT/digital teams, and cross-functional stakeholders, the position drives complex laboratory automation initiatives from concept through implementation, ensures ongoing system performance, and champions innovation in laboratory processes. The incumbent also mentors peers, develops best practices, and influences technical strategy to meet current and future QC department laboratory business needs.Primary Duties:Automation & Instrumentation Strategy
  • Lead the identification, evaluation, and deployment of laboratory automation and instrumentation strategies that improve operational efficiency, data quality, and compliance.
  • Align technology roadmaps with organizational priorities, integrating laboratory systems into broader operational and digital infrastructures.
System Design, Integration & Optimization
  • Design, integrate, optimize methods, provide application storefront input and data report output, in addition to validating automated workflows for sample management, assay execution, analytical testing, and QC processes.
  • Integrate automation hardware (liquid handlers, robotics, storage systems) with scheduling software (e.g., HighRes Cellario, Biosero Green Button Go, Thermo Momentum), LIMS, ELN, and data acquisition systems.
  • Continuously optimize workflows to increase throughput, reduce manual effort, and enhance reliability.
Lifecycle Management & Compliance
  • Own full lifecycle management of laboratory instruments and automation systems, from selection and procurement to installation, qualification (IQ/OQ/PQ), validation, maintenance, and decommissioning.
  • Ensure all systems meet applicable GxP, GLP/GMP, CLIA, FDA, and corporate quality standards.
  • Lead and execute validation plans, change controls, investigations, and CAPAs related to laboratory instrumentation and automation.
Technical Troubleshooting & Continuous Improvement
  • Serve as escalation point for complex laboratory automation and instrumentation issues, conducting investigations that incorporate root cause analysis and implementing corrective/preventive actions.
  • Leverage data analytics to identify trends, prevent failures, and drive proactive maintenance and process improvements.
  • Champion lean, digital, and emerging technology initiatives to advance laboratory capabilities.
Project Leadership & Cross-Functional Collaboration
  • Lead cross-functional automation and instrumentation projects, defining scope, managing risks, and ensuring on-time delivery.
  • Act as technical liaison between QC, R&D, Manufacturing, Engineering, Industrialization, IT/Digital, and external vendors.
  • Influence decision-making at the site level through expert recommendations and data-driven insights.
Documentation, Training & Knowledge Sharing
  • Develop and maintain comprehensive technical documentation, including user requirements, design specifications, SOPs, and validation records.
  • Train scientists, analysts, and technical staff on laboratory automation best practices, laboratory instrument operation, and system troubleshooting.
  • Promote a culture of quality, safety, and innovation through mentorship and knowledge sharing.
Requirements:Bachelor's degree in Engineering, Biological Sciences, Chemistry, Computer Science, or related field with 8+ years of technical and scientific experience working with automated laboratory equipment, data acquisition systems and laboratory instrumentation.Extensive hands-on experience with automated liquid-handling platforms (e.g., Hamilton, Beckman Coulter, Tecan, Agilent) and/or integrated workcells with scheduling software.Proven expertise in instrumentation lifecycle management, workflow automation, method development, and regulated laboratory environments.Experience working with LIMS, ELN, data acquisition systems, and instrument integration.Substantial experience in technical writing in investigations, CAPAs, validation documentation, etc. is required.Experience with regulatory compliance (GxP, GLP/GMP, FDA) and associated documentation requirements.Familiarity with programming languages (e.g., Pascal, Python, C#, Visual Basic) preferred.Demonstrates expertise in analyzing data from automated systems, including performing detailed comparisons between manually collected and system-generated data.Experience in method development and the application of advanced statistical techniques to ensure robust method validation. and basic understanding of data analytics.Knowledge, Skills and Abilities:
  • Impact: Recognized as the site's technical authority for laboratory automation and instrumentation, influencing technology strategy and operational capabilities. Provides leadership and demonstrates mastery in QC laboratory instrument/automation lifecycle management, including procurement, validation, maintenance, troubleshooting, and upgrades. Demonstrates the ability to successfully lead multifaceted technical projects in a matrixed, cross-functional environment
  • Complexity: Leads highly complex, cross-functional initiatives requiring deep technical knowledge and innovative problem-solving. Serves as a subject matter expert in FDA inspections, remediation, and regulatory compliance, ensuring that automation systems and instrumentation meet operational, control, security, and testing requirements.
  • Independence: Operates with minimal supervision, setting technical direction within defined business priorities. Exhibits strong computer, scientific, organizational, analytical, and problem-solving skills.
  • Capable of autonomously managing, prioritizing and resolving complex hardware, software, and process issues.
  • Communication: Regularly interacts with senior leaders, technical experts, and external vendors to influence outcomes. Excellent and effective verbal and written communication skills. Demonstrates the ability to apply a quality mindset across all organizational levels
  • Knowledge: Broad and deep expertise in laboratory automation, instrumentation lifecycle management, compliance, and workflow optimization. Identifies gaps in processes/instrumentation and proactively enacts improvements. Adept at training personnel on new laboratory instrumentation and software, maintaining accurate records, and complying with GLP/GMP regulations and company policies.
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