Data Integrity & Validation Consultant

As a Data Integrity & Validation Consultant, you will join a multi-disciplinary team supporting a large-scale digitalisation program at a leading pharmaceutical client. The program is driven by a strong focus on data integrity (DI). The first phase concentrates on manufacturing, with other areas (such as clinical and laboratory) to follow., * Map and analyse process flows and data flows across manufacturing systems, from where data is generated (PCS, SCADA, HMI and connected systems) to where it is processed, stored, reviewed and reported

• Assess data integrity risks along these flows, in line with GxP expectations and ALCOA+ principles, and identify gaps in controls such as audit trails, access management, data review and backup
• Define and drive remediation actions, and translate your findings into clear, practical recommendations that fit how operations actually run
• Support the validation and compliance of digital and automated manufacturing systems, including preparation, documentation, testing and follow-up, with data integrity as the guiding thread
• Work on the shop floor and close to the business: speak with operators and end users, observe how systems and data are really used day to day, and bring their reality into your deliverables Take initiative, ask the right questions and challenge assumptions, rather than waiting for a detailed brief
• Collaborate with fellow QbD consultants and client stakeholders, and contribute to knowledge-sharing across the engagement
• Where relevant, contribute to the integration and implementation of our proprietary QbD quality management software at client sites

• You hold a master’s degree in a scientific or engineering field (e.g., bio-engineering, industrial engineering, automation, bioinformatics), or have equivalent experience
• You have solid knowledge of data integrity (ALCOA+, GxP, 21 CFR Part 11 / EU Annex 11), ideally with hands-on experience in DI assessments, gap analyses or remediation
• You are comfortable analysing process flows and data flows and can turn them into clear, structured documentation
• You have experience in the Life Sciences industry, ideally in a manufacturing or production environment, and know the basics of computer system validation.
• You know manufacturing automation systems such as PCS, SCADA and HMI. You don’t need to be a deep technical expert, but you can speak the same language as the users and engineers you work with
• Experience with Siemens PCS 7 is a strong plus
• You are fluent in French (required), with a good working level of English
• You are comfortable going to the shop floor, talking to operators, taking the lead and asking questions
• You are detail-oriented, analytical and a clear communicator, with strong problem-solving and project management skills
• You are responsible, curious and adaptable to new challenges, * You’re resilient and tackle challenges with a positive mindset
• You’re curious and always up for learning something new
• You have a no non-sense approach honest, clear, respectful
• You’re innovative and bring ideas, not just opinions
• And above all, you’re serious about your work, but not too serious about yourself

Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices

Grow within a community of experts: Benefit from knowledge-sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise.

Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.

A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations - because your contribution deserves to be valued., We support life sciences companies from idea to patient - offering tailored solutions in development, clinical, regulatory, compliance, production, and distribution. With 500+ experts across 8 countries, we help drive innovation in ATMP, biotech, medical devices, diagnostics, digital health, and pharma.