CQV Engineer

People in Science; Breda; On-site; EUR 53,000 - 88,000; Full time

Job summary

People in Science is seeking a Senior CQV Engineer to support international pharmaceutical manufacturing projects. You will plan, execute and document CQV activities, partnering with Engineering, Project Management and stakeholders to meet GMP, validation and internal quality standards.

Key responsibilities include developing CQV plans and reports, guiding project teams through commissioning and qualification, and ensuring validated solutions align with regulatory and internal SOPs.

Qualifications

• Minimum 3 years of hands-on CQV experience.
• Proven experience with Secondary Packaging equipment, including Print & Inspection systems such as Systech and/or Cognex.
• Hands-on experience with Commissioning and Qualification within Secondary Packaging Operations.
• Experience with Computerized Systems Validation (CSV); HVAC-CSV experience is highly preferred.
• Good understanding of GMP requirements, validation processes and technical documentation.
• Strong understanding of how individual validation documents fit into the overall CQV and project lifecycle.
• Excellent English communication and technical writing skills.
• Able to work independently with minimal supervision.
• Strong analytical, communication and stakeholder management skills.

Responsibilities

• Develop and update validation and commissioning documentation, including Criticality Assessments, CQV Plans, Risk Assessments, Test Protocols, Requirements Traceability Matrices and CQV Summary Reports.
• Lead and execute Commissioning, Qualification and Validation activities.
• Provide technical guidance to project teams to ensure solutions are implemented in accordance with validation plans, GMP requirements and internal SOPs.
• Support project teams throughout design, implementation, testing, commissioning and validation phases.
• Identify issues, set priorities and escalated where required to ensure timely project delivery.

Skills

CQV experience

GMP knowledge

Technical writing

Stakeholder management

Independent work

Tools

Systech

Cognex

Job description

Senior CQV Engineer
We are looking for an experienced Senior Commissioning, Qualification & Validation (CQV) Engineer to support technical projects within an international pharmaceutical manufacturing environment.
In this role, you will be responsible for planning, executing and documenting CQV activities, working closely with Engineering, Project Management and other stakeholders to ensure that technical solutions meet GMP, validation and internal quality requirements.

Key Responsibilities

• Develop and update validation and commissioning documentation, including Criticality Assessments, CQV Plans, Risk Assessments, Test Protocols, Requirements Traceability Matrices and CQV Summary Reports.
• Lead and execute Commissioning, Qualification and Validation activities.
• Provide technical guidance to project teams to ensure solutions are implemented in accordance with validation plans, GMP requirements and internal SOPs.
• Support project teams throughout design, implementation, testing, commissioning and validation phases.
• Identify issues, set priorities and escalated where required to ensure timely project delivery.

Requirements

• Minimum 3 years of hands‑on CQV experience within pharmaceutical manufacturing.
• Proven experience with Secondary Packaging equipment, including Print & Inspection systems such as Systech and/or Cognex.
• Hands‑on experience with Commissioning and Qualification within Secondary Packaging Operations.
• Experience with Computerized Systems Validation (CSV); HVAC-CSV experience is highly preferred.
• Good understanding of GMP requirements, validation processes and technical documentation.
• Strong understanding of how individual validation documents fit into the overall CQV and project lifecycle.
• Excellent English communication and technical writing skills.
• Able to work independently with minimal supervision.
• Strong analytical, communication and stakeholder management skills.

Benefits

A yearly salary up to €87.500,- plus bonus.
This is an excellent opportunity for an experienced CQV professional to contribute to major technical projects within a highly regulated pharmaceutical manufacturing environment.