Validation Analyst

About the Company   Join a leading global pharmaceutical manufacturer where innovation, quality, and patient safety are at the heart of every process. You will become part of a project team focused on improving sterilization processes for sterile pharmaceutical products, contributing directly to product quality and regulatory compliance.

Role Description   As a Validation Analyst, you will play a key role in a strategic validation project focused on optimizing and validating filtration processes used in the manufacturing of sterile medicines. Working closely with engineering, manufacturing, quality, and validation teams, you will investigate existing filtration systems, assess process performance, and develop validation documentation to ensure compliance with GMP and sterilization requirements.

Key Responsibilities     Lead validation activities related to sterile filtration processes
Investigate existing filtration systems and identify opportunities for process improvement
Develop, execute, and review validation protocols, reports, and technical documentation
Assess filtration performance for aqueous and oil-based pharmaceutical formulations
Perform impact assessments and support technical investigations
Ensure validation activities comply with GMP and internal quality standards
Collaborate with Engineering, Manufacturing, Quality Assurance, and Validation teams
Support risk assessments and implement appropriate validation strategies
Analyze validation data and prepare clear technical conclusions and recommendations
Contribute to continuous improvement of sterile manufacturing processes
Requirements     5+ years of experience within the pharmaceutical industry
Demonstrated experience writing validation protocols, technical reports, and GMP documentation
Strong knowledge of GMP and pharmaceutical validation principles
Good understanding of sterile manufacturing processes and filtration technologies
Knowledge of the chemistry of aqueous and oil-based solutions

Experience with process investigations and technical problem solving
Strong analytical skills with a structured and quality-focused approach
Fluent in English (Dutch is considered an advantage but is not required)
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