LIMS and QC Applications Consultant
2 days ago
- Lead the design and development of LabVantage LIMS solutions tailored to business and laboratory needs.
- Develop system workflows, configurations, and integrations with other enterprise systems (e.g., S4 Hana ERP, MES, ELN, SDMS).
- Define data models, interface designs, and system configurations.
- Oversee installation, configuration, and validation of LabVantage LIMS applications.
- Develop and execute project plans, ensuring timely and quality delivery of solutions.
- Manage system customizations, scripts, and user interface enhancements.
- Collaborate with laboratory and IT teams to gather requirements and translate them into technical specifications.
- Serve as the primary point of contact for technical discussions and issue resolution.
- Design and implement integrations between LIMS, SAP and third-party systems, including instruments and databases.
- Automate routine laboratory workflows to increase productivity and accuracy.
- Continuously assess and improve system performance, reliability, and scalability.
- Ensure compliance with regulatory standards, including GxP, FDA, and ISO requirements.
- Provide training and mentorship to end-users and junior developers.
- Create and maintain technical documentation, including system architecture diagrams, user manuals, and SOPs.
- Support validation processes, including IQ/OQ/PQ documentation and audits.
Education:
- Bachelor's degree in Computer Science, Information Systems, Life Sciences, Engineering, or a related field.
- 10+ years of experience managing LABVANTAGE LIMS, QC, or other laboratory-related software systems in the biotech or pharmaceutical industries.
- Proven experience in designing and deploying enterprise-grade LIMS solutions.
- Familiarity with laboratory processes in industries such as pharmaceuticals, biotech, food safety, or environmental testing.
- Demonstrated experience with system validation, particularly in regulated environments (GxP, FDA 21 CFR Part 11, ISO 17025).
- Experience with software development lifecycle (SDLC) methodologies and project management.
- Familiarity with data management practices, including data integrity and governance.
- Expertise in LabVantage LIMS configuration, customization, and scripting (e.g., Java, SQL, Jump).
- Strong knowledge of database management systems (e.g., Oracle, SQL Server).
- Experience with system integrations using APIs, web services, and middleware.
- Familiarity with regulatory frameworks (e.g., GxP, FDA 21 CFR Part 11).
- Ability to work independently and lead cross-functional projects.
- Excellent troubleshooting and problem-solving skills, with a focus on root cause analysis.
- Strong organizational skills with the ability to prioritize tasks effectively.
- Excellent verbal and written communication skills, with the ability to translate technical details into clear, user-friendly language.
- Proven experience with vendor management and negotiation.
- ITIL or similar IT service management certification.
- Certification in LABVANTAGE LIMS software.
- Knowledge of cloud-based LIMS solutions and deployment.
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