Software Development Specialist

LIMS Consultant

We are looking for a client-facing LabVantage LIMS Business Analyst with strong GMP domain expertise and German language proficiency to support global customers. This role requires close interaction with customers, quality teams, and technical stakeholders to deliver compliant, high-quality LabVantage LIMS solutions in regulated environments.

The ideal candidate will combine deep functional knowledge of LabVantage LIMS, excellent communication and presentation skills, and the ability to confidently engage with customers in German-speaking regions.

Key Responsibilities
Client Engagement & Communication
Act as the primary client-facing Business Analyst for LabVantage LIMS engagements.Lead and facilitate requirements workshops, solution discussions, and stakeholder meetings in German and English.
Build strong relationships with customer stakeholders across QC, QA, IT, and business teams.
Clearly articulate solution designs, impacts, and benefits to non-technical audiences.
Business Analysis & Solution Design
Gather, analyze, and document business and functional requirements (URS, FRS, user stories).
Translate laboratory processes into LabVantage LIMS functional designs and workflows.
Perform gap analysis and recommend best-practice solutions aligned with LabVantage capabilities.
Support LIMS configuration including workflows, master data, and role-based access.
GMP & Compliance
Ensure all solutions comply with GMP, GxP, and data integrity principles.
Support Computer System Validation (CSV) activities including URS, FS, IQ/OQ/PQ, and traceability matrices.
Ensure compliance with 21 CFR Part 11 and EU Annex 11 requirements.
Testing, Training & Go-Live Support
Lead and support User Acceptance Testing (UAT) and defect resolution.
Prepare and deliver end-user training, SOPs, and supporting documentation.
Provide post-go-live support and continuous improvement recommendations.
Required Skills & Qualifications
Functional & Technical Skills
Strong hands-on experience with LabVantage LIMS (v7.x / v8.x preferred).
In-depth knowledge of laboratory operations (QC, stability, sample management, batch release).
Experience with LIMS integrations (ERP, instruments, CDS, MES).
Language & Communication
Fluent or professional-level German (spoken and written) – mandatory.
Excellent English and German communication and documentation skills.
Strong presentation skills with the ability to confidently interact with senior client stakeholders.
Business & Consulting Skills
Proven experience in client-facing roles or consulting engagements.
Ability to manage multiple stakeholders and align business and technical teams.
Strong analytical, problem-solving, and decision-making skills.