LIMS Validation & Data Governance Lead

Astek; København; On-site; DKK 800,000 - 1,000,000; Full time

Job summary

Astek is seeking a data management and QA specialist to validate and test a LIMS in a biologics R&D setting. You will ensure data integrity, implement FAIR principles, and collaborate with AGILE teams and stakeholders.

The role involves preparing validation and production‑launch documentation, supporting data governance, and driving continuous improvement through rigorous testing, documentation, and cross‑functional communication.

Qualifications

• Master’s degree or higher in data management, bioinformatics, or a related field.
• Minimum 5 years of experience in data management or biologics R&D.
• Strong knowledge of preclinical research, biologics, and antibody development.
• Understanding of antibody sequencing, pharmacology, biology.
• Experience with MDM systems and data referential management.
• Technical skills: Excel, SQL, Python/R.
• Experience in functional application testing.
• Bonus: experience with Benchling LIMS.
• Proactive, curious, rigorous, autonomous.
• Excellent communication and teamwork skills.
• Fluent in English (required). French is a plus.

Responsibilities

• Conducting technical and functional testing of the LIMS
• Challenging business requirements and implemented features
• Performing file integration and database quality control
• Writing and updating documentation (user guides, business rules, data flows, training materials)
• Understanding biological assays and their integration into the IT ecosystem
• Validating links between MDM systems, expert tools, and the data platform
• Implementing data integrity rules and FAIR principles
• Collaborating with AGILE teams (in vitro / in vivo) and business stakeholders
• Providing decision‑support elements to internal data management leadership
• Leading meetings and writing minutes
• Preparing validation and production‑launch documentation

Skills

Data management

AGILE collaboration

Documentation

Communication

Attention to detail

Fluent English

Education

Master's degree or higher in a relevant field

Tools

Excel

SQL

Python/R

LIMS testing

MDM systems

Job description

Astek is seeking a data management and QA specialist to validate and test a LIMS in a biologics R&D setting. You will ensure data integrity, implement FAIR principles, and collaborate with AGILE teams and stakeholders.

The role involves preparing validation and production‑launch documentation, supporting data governance, and driving continuous improvement through rigorous testing, documentation, and cross‑functional communication.