CSV & Data Integrity Lead

Nalys; Wallonië; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Nalys is seeking a CSV & Data Integrity Lead to join a remediation program at a leading Belgian pharmaceutical site in Brabant wallon. You will reassess data integrity gaps, validate gap closures, and build a defensible risk picture to guide remediation or replacement decisions.

Reporting to the program lead, you will collaborate with quality, engineering, and IT/OT teams, challenge past conclusions with rigor, and document technical justifications for management sign-off.

Qualifications

• Master's degree in engineering, pharmacy, life sciences, or a related field.
• Minimum of 5 years' CSV/Data Integrity experience in GMP environments.
• Fluent with GAMP 5, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+.
• Hands-on experience with data integrity risk assessments on production equipment.
• Experience in regulatory inspections or internal audits (FDA, EMA, or national authorities).
• Strong documentation and ability to challenge conclusions with rigor.

Responsabilités

• Reviewing and revalidating CSV/Data Integrity assessments against current regulatory expectations.
• Reassessing gaps (access management, shared accounts, backup/restore, audit trail) and their criticality.
• Structuring findings by equipment family for scalable remediation.
• Defining mitigation, partial remediation, or full replacement per a 'mitigate first' approach.
• Documenting residual risk and technical justification for recommendations.
• Contributing to a risk-based model applicable across a broader equipment population.
• Liaising with quality, engineering, and IT/OT for sign-off and validation.
• Supporting management-ready deliverables for the program.

Connaissances

CSV/Data Integrity experience

GAMP 5

21 CFR Part 11

EU GMP Annex 11

ALCOA+ principles

Regulatory inspections exposure

English & French communication

Formation

Master's degree in engineering, pharmacy, life sciences, or related field

Description du poste

CSV & Data Integrity Lead – Equipment Remediation Program

? Brabant wallon, Belgium

About Nalys

Nalys is a growing consultancy company specialized in high-tech engineering and life sciences. Founded 15 years ago, we partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains.

At Nalys, we believe in combining deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.

Job Description

As a CSV & Data Integrity Lead, you will join a strategic remediation program for a leading pharmaceutical manufacturing site in Belgium, aimed at reassessing and strengthening data integrity and computerised system validation across a critical population of production equipment.

Reporting to the program lead, you will revisit existing assessments, confirm whether previously identified gaps remain valid, and build the risk-based foundation on which every remediation decision will rest.

This is not a standard execution role: you will challenge and re-validate technical and organizational conclusions established several years ago, and translate them into a defensible, up-to-date risk picture that supports mitigation, remediation, or full system replacement decisions.

We're looking for someone with deep regulatory fluency, sharp critical judgment, and the credibility to defend assessments in front of a demanding quality and engineering organization.

The Role & Responsibilities

Reporting to the program lead and working closely with client quality, engineering, and IT/OT teams, your responsibilities will include:

• Reviewing and revalidating existing CSV/Data Integrity assessments against current regulatory expectations
• Confirming whether previously identified gaps (access management, shared accounts, backup/restore, audit trail) still apply and reassessing their criticality
• Structuring findings by equipment family to support a scalable, risk-based remediation approach
• Defining, for each gap, whether mitigation, partial remediation, or full system replacement is warranted, in line with a "mitigate first" philosophy
• Documenting residual risk and technical justification for every recommended solution
• Contributing to a decision-support model that can be extrapolated across a wider equipment population
• Liaising with quality, engineering, and IT/OT stakeholders to validate findings and secure sign-off
• Supporting the program lead in preparing management-ready deliverables.

Skills & Qualifications

• You hold a master's degree in engineering, pharmacy, life sciences, or a related field
• You have a minimum of 5 years' experience in CSV / Computerised System Validation and Data Integrity within a GMP-regulated environment
• You are fluent in GAMP 5, 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ principles
• You have hands-on experience building or reviewing Data Integrity risk assessments on production equipment
• You are comfortable evaluating access management, audit trail, and backup/restore controls on legacy and modern systems
• You have prior exposure to regulatory inspections or internal audits (FDA, EMA, or national health authorities)
• You can challenge existing technical conclusions with rigor, tact, and clear documentation
• Your English and French communication is clear, structured, and audience-appropriate.

Your Team

This point will be explained in details along the interview.

If you enjoy challenging assumptions, defending your technical judgment, and shaping how a major pharmaceutical site manages data integrity risk, we'd love to hear from you!