LIMS IT Validation Consultant

1 Opening
Krakow

Role Overview

An IT Validation Consultant to lead and support LIMS validation in bioanalytical and clinical research within a regulated (GxP) environment.

This role is ideal for someone with strong LIMS validation experience in regulated environments, who can own documentation, lead testing, and ensure audit readiness, while aligning with business and regulatory needs.

Core Responsibilities:

• Validate LIMS & SampleManager (IQ/OQ/PQ, 21 CFR Part 11).
• Create & review validation docs (URS, FRS, Traceability Matrix, Risk Assessments).
• Ensure compliance with GAMP 5, GxP, data integrity (ALCOA+).
• Work with QA, IT, Labs, Clinical teams to align on system requirements and risks.
• Manage validation for system changes, upgrades, periodic reviews.
• Support audits & defend validation work to regulators/sponsors.
• Train stakeholders on LIMS compliance & validation best practices.

Must-Have Qualifications:

• Degree in Life Sciences/Computer Science / IT.
• 3+ years in IT/CSV validation in life sciences (GxP).
• Hands-on LIMS validation (especially in bioanalysis or clinical research).
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, ICH E6.
• Experience with data integrity, audit trail review, electronic signatures.

We offer:

• Friendly, professional staff and a warm atmosphere.
• The environment where you can implement your ideas.
• Paid vacations and sick leaves.
• Medical insurance.
• Participation in educational activities and thematic conferences.
• Team parties and corporate events.

QA,LIMS,SampleManager