QA Engineer – GMP Validation & CSV Expert

TRIUM Clinical Consulting NV; Breda; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

TRIUM Clinical Consulting NV in the Rotterdam region is seeking an experienced QA Engineer with strong GMP expertise to oversee validation, qualification and change-control activities for equipment, automation and information systems.

You will review documentation, support device and CSV compliance, conduct risk assessments such as FMEA, and collaborate with multidisciplinary teams to ensure data integrity and regulatory alignment across projects.

Qualifications

• Experience with GMP-regulated environments and qualification activities.
• Ability to review validation and change-control documentation.
• Familiarity with data integrity, CSV and risk assessments.

Responsibilities

• Provide QA oversight for validation, qualification of equipment and automation.
• Review and approve validation documentation in line with GMP and regulatory standards.
• Define validation strategies with cross-functional teams and risk assessments.
• Support CSV compliance and data integrity across systems and processes.
• Lead QA input for change controls and QA reviews of technical changes.

Skills

GMP expertise

Equipment qualification

Validation

QA review

Risk management

Education

BSc or MSc in a relevant field

Tools

CSV tooling

FMEA

Quality risk management

Job description

TRIUM Clinical Consulting NV in the Rotterdam region is seeking an experienced QA Engineer with strong GMP expertise to oversee validation, qualification and change-control activities for equipment, automation and information systems.

You will review documentation, support device and CSV compliance, conduct risk assessments such as FMEA, and collaborate with multidisciplinary teams to ensure data integrity and regulatory alignment across projects.