QA Engineer

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

Job Title

Location: Rotterdam region - Hybrid
Type: Full-time

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

Tasks description

• Provide QA support and oversight for the validation and qualification of equipment, automation, processes and information systems.

• Review and approve validation and qualification documentation, ensuring compliance with GMP, regulatory, corporate and site requirements.

• Define and challenge validation strategies in collaboration with Engineering, Manufacturing, Product Development and Information Systems.

• Provide QA guidance during design, characterization, commissioning, qualification and validation activities.

• Support CSV and computer system compliance, including requirements related to GMP, 21 CFR Part 11, EU Annex 11 and data integrity.

• Review validation documentation, protocols, reports, risk assessments and associated technical documentation.

• Review and approve technical changes to equipment, including parameter changes, like-for-like assessments and other equipment modifications.

• Review and approve changes to engineering procedures, including changeover, preventive maintenance and corrective maintenance processes.

• Apply a risk-based approach when assessing technical and engineering changes. Device & Combination Products

• Provide QA oversight for device and combination-product activities.

• Act as QA representative in Quality Risk Management (QRM) activities.

• Facilitate and/or contribute to FMEA, risk assessments and equipment/automation criticality assessments.

• Review quality risk assessment reports and ensure appropriate quality controls are established.

• Ensure site-level risk management activities are aligned with corporate quality policies and strategies.

• Perform the final QA review of technical change controls, ensuring that stakeholder assessments are complete and that all required actions are accurately captured.

• Act as QA SME for technical changes and coordinate input from the relevant QA functions.

• Ensure changes are appropriately assessed for impact on validation, GMP, data integrity and compliance.

What you bring

We are looking for an experienced QA Engineer with a strong background in GMP, equipment qualification, automation/ and validation. In this role, you will act as a QA subject-matter expert supporting engineering, operations and technical teams throughout qualification, validation, change control and quality risk management activities. You will work closely with Product Development, Manufacturing & Engineering and Information Systems to ensure that equipment, processes and computerized systems are designed, qualified and maintained in accordance with GMP, site and corporate requirements

Who you are

The ideal candidate is a hands-on QA/Validation professional who combines technical engineering knowledge with strong GMP expertise. You hold a relevant BSc or MSc degree and have approximately 5-7 years of professional experience in a GMP-regulated environment. You understand how equipment, automation and computerized systems are qualified and validated, but you are equally comfortable reviewing documentation, challenging risk assessments, supporting change controls and working with multidisciplinary project teams. Experience in C&Q, QA review, CSV, data integrity, FMEA, validation documentation and technical change control is particularly relevant.

Our culture is driven by values If this sounds like you, you'll fit right in:

• 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.