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Life Science Consultant, Computerized System Validation

Position: KVALITO Consulting Group, Computerized System Validation Expert
Location: Brussels, Belgium (Hybrid 3 to 4 days onsite per week)
Type: Full-Time (100%)

Mission:
As a CSV Consultant, you will ensure the validation, lifecycle management and compliance of GxP-relevant IT systems in a highly regulated Life Sciences environment. You will be responsible for authoring validation deliverables, managing operational compliance activities, and supporting audit and inspection readiness.

You will directly contribute to the deployment of compliant digital systems that support pharmaceutical innovation and operational excellence.

Key Accountabilities:

IT System Validation:

• Lead and execute validation activities for new and existing GxP IT systems across various domains (e.g., manufacturing, quality, clinical).
• Define and maintain the Project Documentation List per project scope and regulatory requirements.
• Author or review critical validation documents including:
• Validation Plans and Validation Reports
• User Requirement Specifications
• Functional Specifications
• Configuration/Design Specifications
• Installation, Operational, and Performance Qualification Protocols
• Functional Risk Assessments
• Test Strategy Plans and Reports

Data Migration Oversight:

• Support controlled execution of Data Migration activities according to approved plans and validation requirements.
• Document and report data migration results, ensuring data integrity throughout the process.

Operational Compliance Support:

• Actively support Change Management, Deviation Management, Periodic Reviews, and System Retirement processes.
• Ensure Audit, Inspection preparation & readiness and responses related to IT systems.

Project Management & Reporting:

• Ensure adherence to project stage gates following the project management methodology & framework.
• Provide regular updates on project progression, risks, and issues to management and stakeholders.
• Identify and evaluate validation-related issues, concerns, or risks promptly.

Process Improvement & Knowledge Sharing

• Support the development and continuous improvement of CSV frameworks, templates, SOPs, and tools.
• Contribute to internal capability building by mentoring junior team members and sharing industry best practices.
• Help harmonize validation practices across client projects to promote consistency, efficiency, and inspection readiness.

Key Qualifications:

Education

• Bachelor's degree or Master's degree in IT, Life Sciences, Engineering, or a related scientific discipline.
• Equivalent professional experience will be considered.

Language

• Native proficiency in French (oral and written) is mandatory.
• Fluency in English (oral and written) is mandatory.
• Proficiency in additional languages is a plus.

Work Experience

• At least 7 years' hands-on experience in Computerized System Validation in a GxP-regulated environment (pharma, biotech, medtech, CRO/CDMO).
• Proven track record in validation of systems such as LIMS, MES, ERP, CDS, ELN, eQMS, SaaS/cloud platforms, etc.
• Extensive experience authoring and reviewing CSV documentation in compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and industry best practices.
• Proven track record supporting operational quality activities (Change Management, Deviations, Periodic Review, System Decommissioning).
• Familiarity with data migration validation processes is strongly preferred.
• Experience with project governance methodologies and stage-gate project models is advantageous.

Key Competencies

• Strong technical and regulatory understanding of system validation and electronic record compliance.
• Excellent analytical skills and ability to tailor validation strategy to project risk, scope, and constraints.
• Skilled at writing, reviewing, and optimizing validation documentation.
• Ability to work independently in a hands-on role while guiding cross-functional teams.
• Confident in interacting with clients, auditors, and regulatory bodies in both advisory and operational contexts.

You:

• Are driven by impact, passionate about shaping the future of Life Sciences and healthcare through technology and innovation.
• Believe in open communication, speak up, challenge ideas, and engage in meaningful discussions, even with leadership.
• Focus on solutions, not problems, take a proactive approach, looking for ways to improve rather than assigning blame.
• Own your work, take responsibility and accountability seriously, no matter how challenging the situation.
• Commit to excellence, delivering high-performance results while embracing sustainable practices in everything you do.

We:

• Strive to be the best; our mission is to become the world's leading consulting company, empowering high-performing individuals, regardless of gender or neurotype, to reach their full potential and leave a lasting legacy of diversity, equality, inclusion, and excellence.
• Foster a culture of respect, value integrity, fairness, and the unique contributions of every team member.
• See mistakes as opportunities, embrace challenges, learn from them, and continuously improve.
• Prioritize potential over experience, believe intelligence, values, and growth matter more than the number of years on a résumé.

Contact
If you are driven, innovative, and eager to make an impact in Life Sciences consulting, we would love to hear from you.
To apply, send your application to recruiting(at)kvalito.ch, including, your:

• CV, motivation letter, and supporting documents (diplomas, certificates, references)
• Availability, including earliest start date
• Salary expectations
• Location preference

We believe in potential, values, and growth-so if this role excites you, let's connect!
Your KVALITO Team.