Lead IT Validation Consultant

Lead IT Validation Consultant

Remote

Notes :

• Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies. Knowledge of laboratory processes such as PK, TK, and biomarker studies.
• Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).Validation or QA certifications a plus.

JD:

• We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management System (LIMS) used in bioanalytical and clinical research. The ideal candidate will have hands-on experience with LIMS in a regulated GxP environment, ensuring systems are compliant with FDA, EMA, MHRA, and other applicable regulatory requirements.

Key Responsibilities:

• Plan, author, and execute validation activities for LIMS and SampleManager including IQ, OQ, PQ protocols, and 21 CFR Part 11 compliance assessments.
• Develop and review validation documentation: Validation Plans, URS, FRS, Risk Assessments, Traceability Matrix, Validation Summary Reports, etc.
• Ensure LIMS and associated modules are validated in compliance with GAMP 5, GxP, and data integrity principles.
• Collaborate with QA, IT, Laboratory, and Clinical teams to gather requirements, assess risks, and ensure system suitability.
• Participate in change control activities, periodic reviews, and system upgrades from a validation perspective.
• Support audits and inspections by regulatory authorities or sponsors, including preparation of validation documentation and addressing observations.
• Review and verify data integrity and audit trail functionality for compliance with applicable regulatory standards.
• Provide guidance and training to stakeholders on validation best practices and LIMS compliance.

Required Qualifications:

• Bachelor's or Master's degree in Life Sciences, Computer Science, IT, or related field.
• Minimum 3+ years of experience in IT Validation or Computer System Validation (CSV) in a regulated life sciences environment.
• Hands-on experience validating LIMS in bioanalytical or clinical settings.
• Strong understanding of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ principles, and ICH E6 (R2).
• Experience with bioanalytical workflows, clinical sample management, and LIMS data structures.
• Familiarity with audit trail review, electronic signature validation, and data lifecycle management.
• Strong technical documentation and project management skills.

Preferred Qualifications:

• Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies.
• Knowledge of laboratory processes such as PK, TK, and biomarker studies.
• Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).
• Validation or QA certifications a plus.