GxP CSV QA Specialist — Validation & Data Integrity

MindCapture BV; Belgium; Remote; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Meal vouchers

Eco vouchers

Health insurance

Group insurance

Net expense allowance

Company car with charging or fuel card

Job summary

MindCapture BV is seeking an experienced QA CSV Specialist to provide independent quality oversight for computerised systems in a regulated manufacturing environment. The role is on site in Antwerp, Belgium, and involves collaboration with engineering, automation and quality teams to safeguard data integrity and enable inspection readiness.

You will lead validation lifecycle activities, review validation plans and risk assessments, and apply risk-based validation to GxP systems, PLC/SCADA

Qualifications

• Bachelor’s or Master’s degree in Engineering, Automation, Computer Science, Life Sciences or a comparable technical or scientific discipline.
• Typically 4 to 7 years of experience in computerised system validation, quality assurance, automation or computerised systems within a GxP regulated environment.
• Practical experience with validation lifecycle documentation, testing, change control, deviation management and maintaining the validated state.
• Good working knowledge of CSV, SDLC, EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5 and recognised data integrity expectations, including PIC/S guidance.
• Strong understanding of risk based validation, electronic records, electronic signatures, access controls, audit trails, backup and restore, interfaces and supplier documentation.
• Ability to interpret technical system architectures and translate complex system dependencies into clear validation strategies and quality decisions.
• Strong organisational and communication skills, with the confidence to challenge constructively and collaborate effectively with technical and business stakeholders.
• Fluency in English is required. Knowledge of Dutch for local stakeholder interaction is a plus.
• Familiarity with PLC and SCADA systems, industrial automation networks, manufacturing systems or environmental monitoring solutions is a plus.
• Knowledge of directory services, access policies, patch management, antivirus, backup and restore, file transfer services, data flow mapping, periodic reviews or regulatory inspection support is a plus.

Responsibilities

• Take ownership of quality oversight and validation support activities across a range of GxP computerised systems.
• Provide independent quality support throughout system implementation, validation, operation, change management, periodic review and retirement.
• Review and approve validation plans, impact assessments, requirements, risk assessments, specifications, test documentation, traceability matrices and summary reports.
• Evaluate system changes, incidents, deviations, defects and CAPAs for their impact on product quality, patient safety, data integrity and the validated state.
• Apply a pragmatic validation approach focused on critical system functions, electronic records, interfaces and compliance controls.
• Assess access management, audit trails, electronic records, electronic signatures, time synchronisation, backup, restore, retention and data transfer controls.
• Support data flow mapping and assess system boundaries, interfaces, critical records, metadata and control ownership.
• Provide QA support for industrial automation systems, environmental monitoring solutions, network infrastructure and associated IT services.
• Support periodic reviews, regulatory inspections, internal audits and the preparation of compliant validation documentation.
• Work closely with engineering, automation, IT, quality and business stakeholders to resolve compliance challenges and maintain clear accountability.
• Communicate quality risks, challenge validation approaches constructively and elevate significant compliance concerns when necessary.

Skills

CSV validation

GxP compliance

Regulatory knowledge

Data integrity

Risk management

System validation

Documentation

Communication

English fluency

Dutch (plus)

Education

Bachelor’s or Master’s degree in Engineering/Automation/CS/Life Sciences

Experience in computerised system validation

Tools

PLC

SCADA

Job description

MindCapture BV is seeking an experienced QA CSV Specialist to provide independent quality oversight for computerised systems in a regulated manufacturing environment. The role is on site in Antwerp, Belgium, and involves collaboration with engineering, automation and quality teams to safeguard data integrity and enable inspection readiness.

You will lead validation lifecycle activities, review validation plans and risk assessments, and apply risk-based validation to GxP systems, PLC/SCADA