Informacje o stanowisku

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.

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