Senior CQV Engineer, Haarlem, Noord-Holland

The Company
This client focuses on diseases where the need for new medicines is high and the cost high. This multinational is known as one of world’s biggest generic drug manufacturers. In the Netherlands, the core focus areas are neurology and pulmonology and the marketing of products for rheumatological conditions.

Role Description
The Senior CQV Expert is a seasoned specialist responsible for leading and executing validation and re?qualification activities for critical equipment and systems within a pharmaceutical manufacturing environment. This role ensures that all equipment—including steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, and assets requiring airflow visualization or smoke studies—operates in full compliance with regulatory standards, GMP requirements, and internal quality procedures. Acting as a subject matter expert, you will support projects, manage deviations and changes, and contribute to continuous improvement while safeguarding product quality and operational efficiency. 

Responsibilities

• Leading and participating in Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Executing and supporting validation and re?qualification protocols for sterilization equipment, lyophilizers, depyrogenation tunnels, and other production equipment or utilities.
• Managing deviations by documenting, reporting, coordinating corrective actions, and ensuring timely closure.
• Providing technical guidance on validation matters to project teams and internal stakeholders.
• Working closely with cross?functional teams to align validation deliverables with production needs, project milestones, and quality objectives.
• Performing risk assessments and impact analyses for validation activities, recommending suitable mitigation strategies.
• Preparing, reviewing, and evaluating validation data, deviations, and change controls to ensure adherence to regulatory and internal standards.
• Preparing and assessing data for periodic reviews and associated reports.
• Ensuring full compliance with GMP and GDP throughout all validation processes.
• Supporting internal and external audits, representing validation topics as the designated subject matter expert.
• Mentoring and training junior validation personnel, promoting knowledge sharing and best practices. 

Requirements

• Bachelor’s degree or higher in a relevant scientific or engineering field.
• Minimum 4–5 years of experience in validation or commissioning/qualification/validation (CQV) in the pharmaceutical industry.
• Strong understanding of GMP principles, including V?Model and SDLC methodologies.
• Excellent analytical, problem?solving, organizational, and project management skills.
• Collaborative team player with high attention to detail and a proactive, solution?oriented mindset.
• Strong written and verbal communication skills, with the ability to work effectively with multidisciplinary teams. 

Other information
Apply to our vacancy for more information. Looking forward to getting in touch!    

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