Junior Validation Specialist

Opis oferty

We are looking for a motivated person to join us as a Junior Validation Specialist and support our project teams in day-to-day quality assurance and validation activities. This is a great opportunity to grow and strengthen your expertise under the guidance of experts in a demanding regulated environment.

What We Offer

• Access to a benefits program: private medical care, sports card, and group insurance.
• English lessons with a dedicated teacher.
• Access to an extensive training library covering both soft and technical skills.
• Company events, competitions, and challenges.

Who We Are – in Brief

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.

Industry: We operate in the IT sector. Clients: We support international companies in regulated industries (banking, finance, insurance, pharmaceuticals).

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Wymagania

Required Skills and Experience

• Experience working in a validation department is a plus. 
• Commissioning, Calibration / 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). 

Zakres obowiązków

• 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.