- Designing and optimizing batch configurations to ensure process reproducibility and effective penetration of the sterilizing agent.
- Conducting CQV validation and qualification processes in full compliance with applicable standards and international regulatory requirements.
- Monitoring the operation of clean media systems, including clean steam, water for injection, and utility gases such as nitrogen and compressed air.
- Analyzing process deviations and performing engineering troubleshooting, including investigating the causes of moist batches after a cycle or positive biological indicator results.
Workplace: hybrid (Halden)
Workload: Full-time
Type of Contract: B2B
Key Responsibilities
- Designing and optimizing batch configurations to ensure process reproducibility and effective penetration of the sterilizing agent.
- Conducting CQV validation and qualification processes in full compliance with applicable standards and international regulatory requirements.
- Monitoring the operation of clean media systems, including clean steam, water for injection, and utility gases such as nitrogen and compressed air.
- Analyzing process deviations and performing engineering troubleshooting, including investigating the causes of moist batches after a cycle or positive biological indicator results.
Required Skills And Experience
- In-depth and practical knowledge of various sterilization and depyrogenation methods (in particular: thermal, gas, chemical, and radiation sterilization, as well as sterilizing filtration).
- Experience working with advanced process equipment, especially autoclaves and isolators.
- Solid knowledge of the validation and qualification of systems, machines, and processes (knowledge of CQV standards).
- Analytical skills focused on engineering problem-solving in clean media environments.
- Communicative proficiency in English.
What do we offer?
- Benefits package (private health insurance, sports card, group insurance).
- Free English lessons with a dedicated teacher.
- Access to an extensive training library covering both soft and technical skills.
- Sports activities.
- Team-building events, contests, and challenges.
Who We Are – In a Nutshell
Industry: We operate in the IT sector.
Clients: We support international companies in regulated industries (banking, finance, insurance, pharmaceuticals).
Services: We provide comprehensive quality control and implement modern HR platforms for employee management.
How do we work? See what our employees say👉 Piotr i Julia