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von: KVALITO AG
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At KVALITO Consulting Group, a women-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Guided by our vision to lead with talent and transform with purpose, we are committed to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential.
At KVALITO, we embrace diversity, equity, and inclusion in every aspect of our work, fostering a results-oriented, ambitious, and caring culture. Our purpose-driven team is agile and adaptable, ready to learn and respond to evolving business needs. Together, we champion a culture that balances excellence with empathy, utilizing technology and human-centric approaches to drive impactful results.
If you're passionate about making a difference and eager to grow within a company that values inclusivity and high performance, KVALITO could be the place for you. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.
Learn more about us at:
Life Science Consultant, Computerized System Validation Expert
Position: KVALITO Consulting Group, Computerized System Validation Expert
Location: Basel
Type: Full-Time (100%)
Mission: As a CSV Expert, you will serve as a trusted specialist in Computer System Validation across GxP-regulated environments, ensuring that digital and IT systems meet global regulatory expectations and internal quality standards throughout their lifecycle. This role plays a crucial part in enabling digital transformation in Life Sciences by embedding quality and data integrity into IT system implementations, upgrades, and ongoing operations.
At KVALITO, our CSV Experts are hands-on leaders in the field-working closely with Quality Assurance, IT, system owners, and business stakeholders to define and execute risk-based validation strategies for systems such as LIMS, MES, ERP, CDS, ELN, eQMS, and cloud-based platforms. You will contribute deep subject matter expertise while delivering practical, scalable, and compliant validation solutions that support innovation and patient safety.
Key Accountabilities:
System Validation & Lifecycle Compliance:
- Plan, execute, and oversee CSV activities across diverse GxP-regulated systems following a risk-based, value-driven approach.
- Prepare or review validation documentation, including validation plans, user and functional requirements, test protocols, traceability matrices, and summary reports.
- Ensure systems comply with 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity standards.
- Provide quality oversight during implementations, migrations, upgrades, and decommissioning activities.
Subject Matter Expertise & Advisory:
- Act as the CSV SME for cross-functional project teams, providing guidance on regulatory expectations, validation methodologies, and lifecycle management.
- Participate in audits and inspections, supporting client readiness and representing the validation process.
- Support supplier assessments and system evaluations, especially for cloud-based and SaaS solutions.
System Coverage & Adaptability
- ApplyCSV expertise across various system landscapes such as:
- Laboratory Systems (LIMS, CDS, ELN)
- Clinical/Pharmacovigilance Systems
- Manufacturing Systems (MES, SCADA)
- Enterprise Platforms (ERP, eQMS, PLM, DMS)
- Cloud-based / SaaS platforms including emerging AI/ML-enabled technologies
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
- Fluency in English (oral and written) is mandatory.
- Proficiency in additional languages is a plus.
Work Experience
- Hands-on experience in Computer 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 knowledge of relevant regulations and guidance, including GAMP 5, 21 CFR Part 11, EU Annex 11, ALCOA+ principles
- Experience working across complex, multi-system project environments with high compliance demands.
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.
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