Data Integrity & Validation Consultant

QbD Group; Henegouwen; On-site; EUR 65,000 - 95,000; Full time

Job summary

QbD Group in Belgium is seeking a Data Integrity & Validation Consultant to support a major digitalisation program in the Life Sciences sector. You will map data and process flows, assess integrity risks, and drive remediation actions on shop floors.

Collaborative, with a strong focus on compliance with ALCOA+ and GxP principles. You will work on validation and continuous improvement of manufacturing systems, speaking with operators and engineers to translate real-world use into actionable

Qualifications

• Master’s degree in a scientific or engineering field.
• Solid knowledge of data integrity (ALCOA+, GxP, 21 CFR Part 11 / EU Annex 11).
• Experience in DI assessments, gap analyses or remediation.
• Life Sciences industry experience, manufacturing environment.
• Fluent French with a good working level of English.

Responsibilities

• Map and analyse process flows and data flows across manufacturing systems, from data generation to processing/reporting.
• Assess data integrity risks along flows and identify gaps in controls (audit trails, access management, data review, backup).
• Define and drive remediation actions and translate findings into practical recommendations.
• Support validation and compliance of digital/automated manufacturing systems with data integrity as guiding thread.
• Engage with operators and end users on the shop floor to capture reality and inform deliverables.
• Take initiative, ask questions, and challenge assumptions; collaborate with QbD consultants and client stakeholders.
• Where relevant, contribute to integration and implementation of our QbD quality management software at client sites.

Skills

Data integrity

GxP awareness

DI assessments

Documentation

Shop floor liaison

Project management

French language

English language

Education

Master's degree in science/engineering

Tools

Siemens PCS 7

Job description

Data integrity & Validation Consultant

Location : Brabant-wallon
Type : Full-time

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.

What’s in it for you?

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.

What you’ll be doing

You will:

• 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

What you bring

• 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 remediationYou 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

Who you are

• 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

About us

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.

We believe in JPEG :
Joy. Partnership. Going the Extra Mile. Getting Things Done.

You won’t just be taking a job — you’ll be joining a community where people grow, laugh, build, and contribute to something bigger.