IT Validation Consultant

Summary: The IT Validation Consultant role focuses on leading and supporting the validation of Laboratory Information Management Systems (LIMS) within bioanalytical and clinical research settings. The ideal candidate should possess hands-on experience in a regulated GxP environment and ensure compliance with various regulatory requirements. Prior experience in clinical research organizations or pharmaceutical/biotech companies is essential, along with knowledge of laboratory processes. Validation or QA certifications are considered a plus.

Key Responsibilities:

• Lead and support the validation of Laboratory Information Management Systems (LIMS).
• Ensure compliance with FDA, EMA, MHRA, and other regulatory requirements.
• Utilize knowledge of laboratory processes such as PK, TK, and biomarker studies.
• Integrate LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).

Key Skills:

• Experience in clinical research organizations, pharmaceutical, or biotech companies.
• Hands-on experience with LIMS in a regulated GxP environment.
• Knowledge of laboratory processes.
• Validation or QA certifications.

Salary (Rate): undetermined

City: undetermined

Country: USA

Working Arrangements: remote

IR35 Status: outside IR35

Seniority Level: undetermined

Industry: IT