Validation Consultant

Validation Consultant (GxP / CSV / AI & Data Platforms)

Remote / Hybrid

Are you an experienced Validation Consultant with a strong background in regulated environments and a passion for emerging technologies? We're looking for a highly skilled professional to support the validation and compliance of critical digital systems, cloud platforms, and AI-driven solutions within a fast-paced, innovative life sciences environment.

The Opportunity

As a Validation Consultant, you will play a key role in supporting Digital Technology compliance activities, ensuring computerised systems meet regulatory requirements and internal quality standards throughout the system lifecycle.

You will work closely with Quality, Data Engineering, Product, and Security teams to drive compliance, validation excellence, and risk-based decision making across a diverse technology landscape.

Key Responsibilities

Author, review, and approve validation and qualification documentation

Support computer system lifecycle management activities

Ensure compliance with GxP, SOx, Data Privacy, Cybersecurity, and relevant regulatory requirements

Apply industry best practices including GAMP 5, CSA, and Data Integrity frameworks

Manage and maintain quality records including Change Controls, Deviations, CAPAs, and Risk Assessments

Support the development and improvement of validation procedures, SOPs, and templates

Identify, communicate, and help resolve compliance issues and project risks

Collaborate with cross-functional stakeholders to ensure timely delivery of validation activities

What We're Looking For

Significant experience as a Validation Consultant, Computer Systems Validation (CSV) Specialist, or IT Quality professional within pharmaceutical, biotechnology, or other regulated industries

Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, Data Integrity requirements, and risk-based validation methodologies

Strong experience validating cloud-based infrastructure and platforms such as Azure, AWS, or Oracle Cloud

Hands-on experience working with modern data environments including Snowflake, Databricks, Tableau, and Power BI

Experience validating complex AI solutions, including Generative AI and Large Language Models (LLMs), within a regulated setting

Proven ability to influence and collaborate with Quality, Data, Product, and Security stakeholders

Excellent documentation skills and attention to detail

Self-sufficient, pragmatic, and capable of working autonomously

Preferred Background

✔ Bachelor's or Master's degree in Computer Science, Engineering, Pharmacy, Life Sciences, or a related discipline

✔ Strong understanding of global regulatory expectations around data integrity and computerized systems

✔ Fluent English communication skills, both written and verbal

✔ Experience with Veeva, ServiceNow, Jira, ERP, QMS, or other enterprise platforms would be advantageous

Interested?

If you have a strong combination of CSV, Data Platform Validation, Cloud Qualification, and AI Governance experience, we'd love to hear from you. Apply today or contact me directly for a confidential discussion.

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