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Job description
Are you an engineer with a strong background in chemical processes and expertise in cleanroom environments? We are seeking a Chemical Process Engineer to join our team in the medical devices sector.
As a Chemical Process Engineer, you will lead and support critical cleaning, coating, and packaging processes in a controlled cleanroom environment. Your expertise in chemical engineering and process design will be key to ensuring that equipment and processes meet the highest regulatory standards.
What will you do:
Develop, monitor, and optimize chemical processes related to cleaning, coating, and packaging in cleanroom operations.
Oversee and maintain cleanroom equipment such as coating machines, cleaning systems, and specialized packaging machinery, ensuring peak performance.
Collaborate with cross-functional teams, including engineering, quality assurance, and production, to improve process efficiency and resolve technical issues.
Ensure compliance with ISO 13485 and Good Manufacturing Practices (GMP) for medical devices.
Participate in the design, validation, and qualification of new processes, equipment, and systems in alignment with user requirements.
Conduct risk assessments (PFMEA), develop Control Plans, and execute Process Qualifications (PPAP) for product launches and transfers.
Create and maintain detailed process documentation, including validation protocols, testing procedures, and inspection plans.
Train and guide team members on cleanroom protocols and chemical process standards.
What do you need:
Bachelor’s or Master’s degree in Chemical Engineering, Chemistry, Biotechnology, or a related field.
Proven experience in chemical process engineering within cleanroom environments, preferably in the medical devices or pharmaceutical sectors.
In-depth knowledge of cleanroom equipment, contamination control, and chemical processes for coating and cleaning applications.
Strong understanding of industry standards and regulations, including ISO 13485 and GMP.
Demonstrated problem-solving skills and the ability to optimize complex systems under pressure.
Proficiency in process validation, risk management, and regulatory compliance.
Familiarity with tools like SAP and proficiency in MS Office Suite.
Proficient in English and Polish
Preferred Skills:
Additional certifications in GMP, ISO standards, or cleanroom management.