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

Planet Pharma; Belgique; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Planet Pharma is seeking an experienced Validation Consultant to support the validation and compliance of critical digital systems, cloud platforms, and AI-driven solutions within a fast-paced life sciences environment.

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

Qualifications

• Significant experience in Validation/CSV in regulated industries.
• Expert knowledge of FDA 21 CFR Part 11, EU Annex 11, Data Integrity and risk-based validation methodologies.
• Strong experience validating cloud-based infrastructure and platforms (Azure, AWS, Oracle Cloud).
• Hands‑on experience with modern data environments (Snowflake, Databricks, Tableau, Power BI).
• Experience validating AI solutions (Generative AI, LLMs) in regulated settings.
• Proven ability to collaborate with Quality, Data, Product, and Security stakeholders.
• Excellent documentation skills and attention to detail.
• Self‑sufficient, pragmatic, autonomous work style.

Responsabilités

• Author, review, and approve validation and qualification documentation
• Support computer system lifecycle management activities
• Ensure compliance with GxP, SOx, Data Privacy, Cybersecurity and regulatory requirements
• Apply GAMP 5, CSA, and Data Integrity frameworks
• Manage and maintain Change Controls, Deviations, CAPAs, and Risk Assessments
• Develop and improve validation procedures, SOPs, and templates
• Identify and resolve compliance issues and project risks
• Collaborate with cross-functional stakeholders to ensure timely delivery of validation activities

Connaissances

Validation Consultant experience

CSV Specialist

IT Quality professional

GxP Compliance knowledge

Formation

Bachelor's or Master's degree in Computer Science, Engineering, Pharmacy, Life Sciences

Outils

Veeva

ServiceNow

Jira

ERP

QMS

Description du poste

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