CQV Engineer

Overview:

The CQV Engineer will support technical projects under minimal supervision and report to the Sr Manager Validation & Compliance within the site Engineering organization.

The CQV Engineer will demonstrate hands-on commissioning and qualification skills, including but not limited to developing, implementing and reporting test strategies for technical solutions in accordance with internal customer requirements and standard CQV procedures. The CQV Engineer will drive the development of system commissioning, qualification and validation documentation.

Location: North Brabant, The Netherlands

Key Responsibilities:

Documentation

• Develop and update validation documents, including:
• System Level Criticality Assessments
• Validation, Commissioning and Qualification Plans
• Risk Assessments
• Test Protocols
• Requirement Traceability Matrices
• Commissioning, Qualification and Validation Summary Reports

Testing

• Lead Commissioning, Qualification and Validation activities.

Technical Support

• Provide guidance to project teams to ensure technical solutions are implemented according to validation plans, internal requirements and applicable SOPs.

Additional Responsibilities

• Perform any other tasks or projects assigned by the supervisor.

Basic Qualifications & Experience

• Experience with Secondary Packaging Systems, including Print and Inspection Systems (e.g. Systech, Cognex).
• Minimum 3 years of experience executing Commissioning, Qualification and Validation activities within pharmaceutical manufacturing organizations.
• Experience in Computerized Systems Validation (CSV).
• Hands-on commissioning and qualification experience within Secondary Packaging Operations.
• Strong understanding of how individual validation documents fit within the broader validation strategy.
• Experience working with internal and external stakeholders.

Preferred Qualifications & Experience

• Ability to work independently and remotely with minimal supervision.
• Strong technical writing skills in English.
• Excellent communication and stakeholder management skills.
• Strong critical thinking and problem-solving skills.
• Ability to set priorities and escalate appropriately to ensure timely delivery of project phases, including design, development, implementation, testing, construction, commissioning and validation.
• Experience within a GMP-regulated environment and understanding of compliance practices, procedures and documentation requirements.
• Ability to anticipate, assess and resolve multiple project issues, delays and challenges using both technical and business expertise.