Junior Validation Specialist

We are a leader in technology services for companies in regulated industries. We have delivered hundreds of projects for clients around the world and bring over 24 years of market experience, with a particular focus on areas such as life sciences, QA, validation, cloud systems, human capital management (HCM), and Salesforce.

• Experience working in a validation department is a plus.
• Knowledge of commissioning, calibration, and hot loop checks.
• Knowledge of key regulations and requirements: EU GMP, FDA, and GAMP 5.
• Knowledge of ALCOA+ principles and the ISO 14644-3 standard.
• Confidence working with technical documentation and the ability to prepare validation documentation.
• Teamwork skills, attention to detail, and reliability.

Nice to have:

• Knowledge of the PN-EN 285 and PN-EN 12469 standards relating to autoclaves and laminar flow cabinets.

• Preparing and updating validation documentation based on technical documentation, and supporting the analysis of user requirements (URS).
• Taking responsibility for the course of validation processes, including thorough and accurate test execution and maintaining organizational standards.
• Qualification of production and laboratory equipment (including autoclaves and laminar flow cabinets).
• Performing measurements and mapping in cleanrooms (including temperature, humidity, airflow, pressure cascade, and HEPA filter integrity).
• Providing ongoing expert support to project teams in day-to-day quality and validation activities.