Process Validation Specialist

• Validation strategy and documentation: drafting and maintaining validation master plans, validation protocols, reports, and associated risk analyses.
• Process validation: preparing and executing process validations to demonstrate that production processes consistently and reproducibly meet defined specifications.
• Equipment qualification: coordinating and executing qualifications of production equipment and supporting systems, where applicable according to the principles of IQ, OQ, and PQ.
• Interdepartmental collaboration: coordinating validation activities in collaboration with Production, R&D, and Quality Assurance, with attention to planning, resources, and deadlines.
• Quality assurance and compliance: ensuring that validation activities are performed according to approved protocols, safety regulations, and applicable quality procedures.
• Deviations and improvements: investigating and documenting deviations during validations and contributing to root cause analyses, corrective actions, and process improvements.
• Change management: assessing changes to processes, equipment, materials, and production parameters for their potential impact on the validated status and the need for requalification or revalidation.
• Validation files: ensuring complete, traceable, and audit-proof validation documentation that complies with the requirements of the ISO 13485 quality management system.

What they ask Education and experience.

• Master's degree in a scientific, medical, or technical field, or equivalent through experience.
• Preferably 3 - 5 years of relevant experience with process validation within a medical device company.
• Experience with risk analysis and risk management.
• Experience with statistical process analysis, process capability, and equipment qualification is a strong asset.

Technical and regulatory knowledge.

• Thorough knowledge of ISO 13485 and the European MDR (EU 2017/745).
• Understanding of the principles of process validation and knowing when process verification is sufficient versus when validation is necessary.
• Familiarity with risk-based working and drafting technical protocols and reports.
• Knowledge of statistical techniques for process characterization, data analysis, and process capability assessment.
• Knowledge of GMP principles and experience with equipment qualification are a plus.

Personal skills.

• Work accurately, analytically, and methodically, with an eye for detail and compliance.
• Strong in planning, organizing, and following up on multiple activities and deadlines.
• Communicate clearly and enjoy collaborating with various departments.
• Take initiative, think solution-oriented, and dare to critically evaluate existing processes.
• Able to document technical findings clearly and substantiated.
• Good oral and written knowledge of Dutch and English.

• You will join a professional working environment with room for initiative.
• Opportunities for further development and training are available.
• You will work in a collegial and supportive team.