(CQV) Engineer

Real; Breda; On-site; EUR 70,000 - 110,000; Full time

Job summary

Real is seeking a CQV Engineer/Senior CQV Engineer in Breda, Netherlands. The role focuses on commissioning, qualification and validation of manufacturing and packaging systems within a GMP-regulated environment.

Depending on experience, you may execute validation activities or lead CQV strategies across multiple project streams. Reporting to the Senior Manager, Validation & Compliance, you will ensure IQ/OQ/PQ execution, maintain validation documentation, and guide teams while meeting timelines

Qualifications

• Minimum 3 years of CQV experience within pharmaceutical manufacturing.
• Experience with Secondary Packaging Systems.
• Experience with Print & Inspection Systems such as Systech and Cognex.
• Experience with Computerised Systems Validation (CSV).
• Hands-on experience executing commissioning and qualification activities.
• Strong understanding of GMP-regulated environments.

Responsibilities

• Develop, review, and maintain validation lifecycle documentation (e.g., RTMs, VPs, test protocols).
• Lead validation strategy development and oversee complex CQV programmes.
• Execute and/or lead IQ, OQ, PQ for manufacturing and packaging equipment.
• Document test results and manage deviations.
• Ensure validation deliverables are on time and compliant with project/quality requirements.
• Mentor junior engineers and serve as CQV escalation point.

Skills

CQV experience

Validation execution

Technical writing

Stakeholder management

Problem solving

Independent worker

Leadership

Tools

Systech

Cognex

CSV

Job description

Location: Breda (Netherlands)

Contract: 12-month (Extension possible)

Hours: 40 hours per week

Working pattern: Primarily onsite, with occasional flexibility depending on project requirements.

The Opportunity

We are seeking a CQV Engineer / Senior CQV Engineer to support engineering, validation, and compliance projects within a GMP-regulated pharmaceutical manufacturing environment.

Reporting to the Senior Manager, Validation & Compliance, you will play a key role in the commissioning, qualification, and validation of manufacturing and packaging systems. Depending on your level of experience, you will either execute validation activities or lead validation strategies and complex CQV programmes across multiple project workstreams.

Key Responsibilities

• Develop, review, and maintain validation lifecycle documentation, including:
• System Criticality Assessments
• Validation Plans
• Test Protocols
• Requirements Traceability Matrices (RTMs)
• Validation Summary Reports
• Ensure all documentation complies with GMP requirements and internal procedures.
• For Senior-level candidates: lead validation strategy development and provide technical oversight for complex systems.
• Execute and/or lead commissioning, qualification, and validation activities for manufacturing and packaging equipment.
• Support or lead IQ, OQ, and PQ execution.
• Document test results and manage deviations where required.
• Ensure validation deliverables are completed on time and in compliance with project and quality requirements.

Technical Support & Leadership

• Provide CQV and compliance expertise to project teams.
• Support troubleshooting, risk assessments, and technical decision-making.
• Review technical documentation and ensure alignment with validation requirements.
• Senior candidates will act as a subject matter expert, mentor junior engineers, and serve as an escalation point for CQV and CSV-related challenges.

Compliance & Continuous Improvement

• Maintain compliance with GMP regulations and internal quality standards.
• Support audits and inspections when required.
• Identify opportunities to improve validation processes, documentation standards, and project execution practices.

What We're Looking For

• Minimum 3 years of CQV experience within pharmaceutical manufacturing.
• Experience with Secondary Packaging Systems.
• Experience with Print & Inspection Systems such as Systech and Cognex.
• Experience with Computerised Systems Validation (CSV).
• Hands-on experience executing commissioning and qualification activities.
• Strong understanding of GMP-regulated environments.
• Minimum 5 years of CQV experience within pharmaceutical manufacturing.
• Extensive experience with Assembly and Secondary Packaging Equipment Qualification.
• Strong experience with Serialization, Systech, Cognex, and CSV.
• Experience with HVAC qualification and validation activities.
• Proven track record in leading validation programmes and developing validation strategies.
• Experience reviewing and approving validation documentation and guiding project teams.
• Strong technical writing and documentation skills.
• Excellent communication and stakeholder management abilities.
• Analytical mindset with strong problem-solving capabilities.
• Ability to work independently and manage multiple priorities.
• Experience working within GMP-regulated pharmaceutical environments.

Why Join?

This is an opportunity to contribute to high-impact validation and compliance projects within a leading pharmaceutical manufacturing environment. You will work closely with engineering, quality, and project teams while helping deliver critical manufacturing and packaging systems that meet the highest quality and regulatory standards.