CQV Engineer

NES Fircroft; Breda; Ibrido; EUR 50.000 - 54.000; Tempo pieno

Descrizione del lavoro

NES Fircroft is seeking a CQV Engineer to join a globally recognized biotech environment in the Netherlands. The role focuses on leading commissioning, qualification and validation activities across packaging and CSV systems, ensuring GMP compliance.

You'll work in a hybrid setup (1–2 days from home), approximately 40 hours per week, with a 12-month contract and renewal potential. Strong writing and communication skills in English are essential.

Competenze

• Minimum 3 years’ CQV experience in pharmaceutical manufacturing.
• Hands-on experience with secondary packaging systems, including print & inspection (e.g., Systech, Cognex).
• Experience in computerized systems validation (CSV).
• Strong understanding of validation documentation and its role within projects.

Mansioni

• Develop, update, and manage validation documentation (e.g., criticality assessments, validation/commissioning/qualification plans, risk assessments, test protocols, traceability matrices, summary reports).
• Lead commissioning, qualification, and validation (CQV) activities.
• Define, implement, and report testing strategies aligned with internal requirements and CQV procedures.
• Support project teams to ensure solutions comply with validation plans and SOPs.
• Drive system CQV documentation and execution.
• Perform additional tasks as assigned.

Conoscenze

CQV experience

Packaging systems

CSV validation

Technical writing

Communication skills

Stakeholder management

Problem solving

GMP knowledge

Project delivery

Strumenti

Systech

Cognex

Descrizione del lavoro

o you want to be part of a world wide organization recognized as World's Best Workplace with the mission of saving patients through advanced biotech technologies?

Our client's products reach over 10 million patients worldwide, that is why we are supporting them in looking for a The CQV Engineer will support technical projects under minimal supervision and will report to Sr Manager Validation& Compliance within the site Engineering organization.

Contract Length:12 months (possibility of renewal)

Hybrid (1 or 2 days from home depending on project needs) - 40h a week

Salary range: 4500 - 4800 EUR/month

NO SPONSORSHIP AND NO RELOCATORS FROM OUTSIDE THE NETHERLANDS

Responsibilities

• Develop, update, and manage validation documentation (e.g., criticality assessments, validation/commissioning/qualification plans, risk assessments, test protocols, traceability matrices, summary reports)
• Lead commissioning, qualification, and validation (CQV) activities
• Define, implement, and report testing strategies aligned with internal requirements and CQV procedures
• Support project teams to ensure solutions comply with validation plans and SOPs
• Drive system CQV documentation and execution
• Perform additional tasks as assigned

Requirements

• Minimum 3 years’ CQV experience in pharmaceutical manufacturing
• Hands-on experience with secondary packaging systems, including print & inspection (e.g., Systech, Cognex)
• Experience in computerized systems validation (CSV)
• Strong understanding of validation documentation and its role within projects
• Ability to work independently with minimal supervision
• Strong technical writing and communication skills (English)
• Good stakeholder and customer management skills
• Strong problem-solving and prioritization abilities
• Knowledge of GMP compliance and project lifecycle (design through validation)
• Ability to manage multiple issues and deliver projects on time