Senior Validation Specialist, Haarlem, Noord-Holland

Company
Our client is a global leader in the production of generics and biopharmaceuticals. The aim is to develop new and innovative treatments and to offer patients more affordable solutions in different therapeutic areas. They have a complex global supply chain able to reach more than 60 counties. 
 
Job Description
We are seeking an experienced Senior Validation Specialist to join our client's team. In this role, you will lead validation activities related to critical equipment and manufacturing processes, ensuring compliance with industry regulations and internal quality standards. The ideal candidate will play a key role in maintaining operational integrity and supporting manufacturing excellence.
 
Responsibilities

• Lead and execute equipment qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support validation and re-qualification of equipment such as steam sterilizers/autoclaves, lyophilizers, depyrogenation tunnels, and validation of airflow and smoke studies.
• Document deviations, coordinate corrective actions, and ensure proper close-out procedures.
• Provide technical guidance on validation-related issues to project teams and stakeholders.
• Collaborate with cross-functional teams to align validation activities with production schedules and project timelines.
• Conduct risk assessments and impact analyses, proposing mitigation strategies where necessary.
• Review and assess validation data, deviations, change controls, and periodic review reports to ensure regulatory compliance and quality standards.
• Maintain adherence to GMP and GDP standards during all validation activities.
• Support internal and external audits, providing subject matter expertise and effective communication with regulatory authorities.
• Mentor and train junior validation team members, sharing best practices and technical knowledge.

• Bachelor’s degree or higher in a scientific or engineering field.
• 4-5 years of experience in validation or re-qualification within the pharmaceutical industry.
• Strong understanding of GMP, V-Model, and SDLC methodologies.
• Excellent problem-solving, organizational, and project management skills.
• Effective communicator with the ability to collaborate across teams.
• Detail-oriented, with a proactive and can-do attitude.

57287