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.

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.

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

• You hold a masters 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 dont 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

Our culture is driven by values If this sounds like you youll fit right in:

• Youre resilient and tackle challenges with a positive mindset

• Youre curious and always up for learning something new

• You have a no non-sense approach honest clear respectful

• Youre innovative and bring ideas not just opinions

• And above all youre serious about your work but not too serious about yourself

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 wont just be taking a job youll be joining a community where people grow laugh build and contribute to something bigger.

Interested Lets talk.
Send us your CV and motivation letter. You could be the next one to join the QbD family.