Job SummaryWe are seeking an experienced ELN Business Analyst / Laboratory Informatics Specialist to support Electronic Laboratory Notebook (ELN) solutions within a regulated pharmaceutical, biotechnology, or life sciences environment. The successful candidate will work closely with laboratory scientists, quality teams, business stakeholders, and IT teams to gather requirements, optimize laboratory workflows, support system implementations, and ensure compliance with industry regulations.
This role requires strong experience with laboratory informatics platforms such as Benchling, BIOVIA ELN, LabWare, STARLIMS, LabVantage, or similar systems, along with a solid understanding of laboratory operations and regulated environments.
Key Responsibilities- Gather, analyze, and document business and functional requirements for ELN and laboratory informatics solutions.
- Partner with laboratory scientists, QA, QC, Manufacturing, and IT teams to improve laboratory processes and workflows.
- Support ELN implementation, configuration, enhancement, and integration activities.
- Translate business requirements into functional specifications and user stories.
- Facilitate workshops, stakeholder meetings, and requirement-gathering sessions.
- Support system validation activities including User Acceptance Testing (UAT), test script development, and documentation.
- Ensure compliance with GMP, GxP, 21 CFR Part 11, ALCOA+, and data integrity requirements.
- Investigate and resolve ELN-related issues and collaborate with technical teams and vendors for resolution.
- Develop and maintain SOPs, training materials, process documentation, and user guides.
- Participate in change management, release management, and system upgrade activities.
- Support data migration and integration initiatives involving laboratory systems.
Required Qualifications- Bachelor's degree in Life Sciences, Chemistry, Biotechnology, Computer Science, Information Systems, or a related discipline.
- 3+ years of experience working as a Business Analyst, Laboratory Informatics Specialist, ELN Consultant, or similar role.
- Hands-on experience with one or more ELN platforms:
- Benchling
- BIOVIA ELN
- LabWare
- STARLIMS
- LabVantage
- Thermo Fisher SampleManager
- Strong understanding of laboratory operations and scientific workflows.
- Experience working within GMP/GxP-regulated environments.
- Knowledge of Computer System Validation (CSV) methodologies.
- Excellent stakeholder management, communication, and documentation skills.
Preferred Qualifications- Experience supporting pharmaceutical, biotechnology, or medical device organizations.
- Knowledge of laboratory data management, sample lifecycle management, and laboratory workflows.
- Experience with Agile methodologies and project delivery.
- Familiarity with SQL, reporting tools, and system integrations.
- Experience working on global laboratory transformation or digitalization initiatives.
Key Skills- Electronic Laboratory Notebook (ELN)
- Laboratory Informatics
- Business Analysis
- Requirements Gathering
- GMP / GxP Compliance
- Computer System Validation (CSV)
- User Acceptance Testing (UAT)
- Data Integrity
- Laboratory Operations
- Stakeholder Management
- Change Management
- Benchling, BIOVIA ELN, LabWare, STARLIMS, LabVantage
