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Job description
Are you a detail-oriented, chemistry-savvy professional with experience in cleanroom environments? We are looking for a an Engineer with Cleanroom and/or Chemical experience to join our medical devices team, playing a pivotal role in maintaining the highest standards of cleanliness and precision in our controlled cleanroom environment. This position requires a strong background in chemistry or chemical engineering, as well as a passion for ensuring process quality and compliance in a regulated industry.
Key Responsibilities:
Execute specialized cleaning, coating, and packaging processes to meet stringent medical device manufacturing protocols.
Maintain rigorous contamination control and cleanliness standards in the cleanroom.
Monitor and optimize equipment performance and process parameters, ensuring consistent product quality.
Collaborate with quality assurance, engineering, and production teams to enhance processes and resolve issues.
Conduct regular inspections and keep meticulous records of process outcomes, ensuring data integrity.
Adhere to ISO 13485 and GMP standards, ensuring full regulatory compliance within the cleanroom environment.
Train team members on cleanroom protocols, safety, and contamination control.
Lead in PFMEA, Control Plans, SOP, and PPAP (process qualifications for product launches and transfers).
Qualifications:
Bachelor’s degree in Chemistry, Chemical Engineering, Biotechnology, or a closely related field.
Demonstrated expertise in cleaning and coating applications within controlled environments.
Proficiency in cleanroom contamination control, equipment operation, and industry-specific regulations.
Strong analytical and problem-solving skills with a focus on process improvement.
Ability to work autonomously in a high-stakes, regulated setting.
Familiarity with SAP and proficiency in MS Office Suite (Word, PowerPoint, Outlook, Excel).
Preferred Qualifications:
Additional certifications in GMP, ISO standards, or cleanroom management.
Communicative Polish and English language skills.