CQV Engineer

Role Overview

We are looking for an experienced Commissioning, Qualification & Validation (CQV) Engineer to support validation activities within a highly regulated pharmaceutical manufacturing environment.

In this role, you will contribute to the commissioning, qualification, and validation of equipment, systems, and facilities, ensuring compliance with cGMP requirements and industry regulations.

You will collaborate closely with engineering, quality, and operations teams to ensure that equipment and infrastructure are installed, tested, and validated according to regulatory and internal quality standards.

Key Responsibilities

Validation & Qualification Activities

• Support and coordinate the installation, commissioning, and qualification of equipment, systems, and utilities

• Prepare and execute validation protocols including:

  • IQ (Installation Qualification)

  • OQ (Operational Qualification)

  • PQ (Performance Qualification)

• Document validation results in accordance with cGMP standards

Validation Lifecycle Management

Participate in all stages of the validation lifecycle, including:

• Facilities and utilities validation

• Process validation activities

• Risk assessments and gap analyses

• Preparation and review of validation documentation

Typical deliverables include:

• User Requirement Specifications (URS)

• Design Qualification (DQ)

• Failure Mode and Effects Analysis (FMEA)

• Risk Assessments

• Factory Acceptance Tests (FAT)

• Site Acceptance Tests (SAT)

• Validation protocols and reports (IQ/OQ/PQ)

Documentation & Compliance

• Prepare and review validation documentation and reports

• Ensure documentation meets regulatory and quality standards

• Maintain accurate records of validation activities

• Contribute to continuous improvement of validation processes and methodologies

Quality Systems & Engineering Support

• Support quality system activities including:

  • document management

  • change control

  • deviation and non-conformance handling

  • CAPA management

• Assist the engineering team in establishing:

  • validation strategies

  • requalification programs

  • maintenance validation frameworks

• Write and revise engineering procedures where required

Continuous Improvement

• Identify opportunities to improve validation efficiency and processes

• Apply lessons learned across validation programs

• Stay informed about industry standards and regulatory developments

Requirements

Education

Bachelor’s degree in:

• Engineering

• Life Sciences

• Pharmaceutical Sciences

• or a related technical field

Experience

• 5–10 years of experience in the pharmaceutical industry

• Strong experience in commissioning, qualification, and validation (CQV)

• Experience working in GMP-regulated environments

Technical Skills

• Strong knowledge of validation lifecycle methodologies

• Experience validating:

  • pharmaceutical equipment

  • utilities

  • facilities

• Familiarity with risk-based validation approaches

• Excellent technical documentation and reporting skills

Soft Skills

• Strong organizational and time management skills

• Ability to work effectively in cross-functional teams

• Excellent written and verbal communication skills

• Ability to manage multiple tasks in a fast-paced project environment

Languages

• German – Fluent (mandatory)

• English – Professional level

Work Environment

• Full-time onsite presence required in Visp

• Work within a highly regulated pharmaceutical production environment

• Collaboration with engineering, quality, validation, and operations teams

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