Clean room Specialist

Job Description & Skill Requirement

•    Execute cleaning, coating and packaging procedures in accordance with the defined protocols for medical device manufacturing.
•    Maintain a high level of cleanliness and contamination control in the cleanroom environment.
•    Monitor and optimize equipment performance and process parameters to ensure product quality.
•    Collaborate with quality assurance, engineering, and production teams to implement process improvements.
•    Conduct routine inspections and maintain detailed records of process performance and outcomes.
•    Ensure compliance with industry regulations, including ISO 13485 and GMP standards.
•    Train and guide other team members on cleanroom protocols and safety procedures.
•    Participate in PFMEA (Process Failure Mode and Effect Analysis), Control Plan, SOP (Start of Production) and PPAP (Production Part Approval Process) (Stryker internal process qualification generation associated with product transfers and launches). 
•    Define User Requirement Specifications (URS) and support the procurement of equipment.
•    Conduct testing and prepare process documentation for cleanroom operations.
•    Define parameters for executing validation protocols and ensure adherence to them.
•    Lead training and oversee the development of documentation related to cleanroom processes.
•    Support the preparation and execution of inspection plans and ensure data is uploaded into systems like SAP.

Language Skills: 
•    Communicative Polish   
•    Communicative English  

Qualification:

•    Bachelor’s degree in Chemistry, Chemical Engineering, Biotechnology, or a closely related field.
•    Additional certifications in cleanroom management, GMP, or ISO standards are a plus.

•    2-3 years of experience in cleanroom environments, ideally within the medical devices or pharmaceutical industry.(R)
•    Proven experience in the cleaning and application of coatings in a controlled environment. (R)
•    Solid understanding of cleanroom processes, contamination control, and regulatory requirements for medical devices. (R)
•    Ability to work effectively under pressure in a regulated, high-stakes environment. (R)
•    Familiarity with equipment and technology used in cleanrooms, such as coating machines, cleaning systems and packaging. (R)
•    Demonstrable strong analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced environment (R) 
•    Demonstrable ability to work autonomously (R) 
•    Proficient in MS Word, PowerPoint, Outlook, and Excel  (R)