Qualification Engineer

Talentmark; Breda; On-site; EUR 70,000 - 100,000; Full time

Job summary

Talentmark is seeking an experienced Senior Commissioning, Qualification & Validation (CQV) Engineer to support technical projects in an international pharmaceutical manufacturing environment. You will plan, execute and document CQV activities, collaborating with Engineering, Project Management and other stakeholders to ensure GMP compliance and validation deliverables.

Responsibilities include developing CQV plans, risk assessments and test protocols; leading CQV activities; guiding project

Qualifications

• Minimum 3 years hands-on CQV experience in pharmaceutical manufacturing.
• Experience with secondary packaging equipment and print/inspection systems (Systech/Cognex).
• Experience with Computerized Systems Validation (CSV); HVAC-CSV preferred.
• Strong GMP knowledge and ability to document validation artifacts.

Responsibilities

• Develop and update validation and commissioning documentation (CQV Plans, Protocols, & summaries).
• Lead and execute CQV activities across projects.
• Provide guidance to project teams to meet validation plans and SOPs.
• Support design, testing, commissioning, and validation phases.
• Identify issues, set priorities, and escalate for timely delivery.

Skills

CQV experience

GMP knowledge

Technical writing

Stakeholder management

Independent work

Tools

Systech

Cognex

Job description

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 elevate 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.

This is an excellent opportunity for an experienced CQV professional to contribute to major technical projects within a highly regulated pharmaceutical manufacturing environment.