Automation and Laboratory Systems Manager

The Automation and Laboratory Systems Manager oversees the implementation, maintenance, and optimization of automation technologies and digital platforms across laboratory environments. This role ensures seamless integration of instruments, software systems (e.g., LIMS, ELN, CDS), and automated workflows to improve lab efficiency, compliance, and data integrity.

The manager serves as the primary liaison between lab users, IT, vendors, and automation engineers—leading the lifecycle of laboratory digital systems and ensuring alignment with operational and regulatory requirements.

Key Responsibilities:

• Lead the design, deployment, and support of laboratory automation and informatics systems.

• Manage integration of lab equipment with enterprise systems (e.g., LIMS, ELN, CDS, MES, SCADA).

• Supervise automation engineers, application specialists, and validation personnel.

• Oversee the installation, qualification (IQ/OQ/PQ), and lifecycle management of lab equipment and software.

• Define and enforce data integrity, cybersecurity, and regulatory compliance standards (e.g., 21 CFR Part 11, GxP).

• Collaborate with cross-functional teams (QA, IT, R&D, Operations) to align automation strategies with business goals.

• Coordinate with vendors for system customization, maintenance, and support.

• Implement digital dashboards for monitoring lab KPIs, equipment uptime, and throughput.

• Manage projects for system upgrades, migrations, and digital transformation initiatives.

Key Focus Areas:

1. Laboratory Automation Strategy & Execution

   • Automate routine lab workflows such as sample prep, assay execution, and result reporting

   • Optimize throughput, reproducibility, and traceability using robotics and scheduling software

2. System Integration & Data Flow

   • Ensure seamless connectivity between lab instruments, middleware, and enterprise platforms

   • Manage HL7/FHIR/API-based integration and instrument interface development

3. Digital Laboratory Infrastructure

   • Lead implementation and optimization of LIMS, ELN, CDS, and supporting platforms

   • Align system configurations with lab protocols, compliance, and user needs

4. GxP Compliance & Validation

   • Oversee computerized system validation (CSV) for lab systems

   • Ensure compliance with regulatory frameworks (FDA, ISO, GLP/GMP, 21 CFR Part 11)

5. Equipment Lifecycle & Maintenance Management

   • Track lab automation asset inventory, calibration, and preventive maintenance schedules

   • Collaborate with metrology and engineering teams for support and troubleshooting

6. Team Leadership & Vendor Oversight

   • Manage lab systems staff and vendor performance

   • Lead training, change management, and support across departments

7. Lab Digitalization & Analytics

   • Deploy data visualization tools and dashboards to drive data-informed decisions

   • Support predictive maintenance and real-time monitoring initiatives

Qualifications:

• Education:

  • Bachelor’s or Master’s degree in Engineering, Computer Science, Laboratory Science, or a related technical field

  • Certification in LIMS/ELN platforms or CSV methodology is a plus

• Experience:

  • 7–10 years of experience in laboratory automation, informatics, or related digital transformation roles

  • Proven experience managing lab automation projects in pharma, diagnostics, or biotech industries

  • Knowledge of regulated laboratory environments (GLP/GMP/CLIA/CAP)

• Technical Skills:

  • Hands-on with LIMS (LabWare, LabVantage, STARLIMS), ELN (Benchling, IDBS), CDS (Empower, Chromeleon)

  • Familiarity with scripting, API integration, SQL, and GAMP 5 validation principles

  • Strong understanding of automation hardware, robotics, scheduling software (e.g., HighRes, Hamilton, Tecan)

• Leadership & Soft Skills:

  • Excellent communication, project management, and team leadership skills

  • Ability to manage cross-functional teams and multiple stakeholders