Cleanroom Engineer

Role and Responsibilities

The Cleanroom/Sterilization Engineer will be responsible for maintaining the cleanliness and sterility of the clean room environment and the product produced in that environment, ensuring compliance with industry and regulatory standards. Key responsibilities include clean room maintenance, sterilization procedures, equipment upkeep, quality control, compliance with regulations, and safety protocols. The ideal candidate should possess relevant experience, a strong attention to detail, and a commitment to maintaining sterile conditions in the medical device manufacturing process.

 

Responsibilities:

• Monitor and maintain proper environmental conditions, such as temperature, humidity, and airflow.
• Handle and dispose of hazardous waste materials according to safety protocols.
• Operate cleanroom equipment in accordance with established procedures.
• Review sterilization cycle paperwork ensuring they meet the required parameters to release the product.
• Perform routine maintenance of clean room equipment.
• Troubleshoot equipment issues and initiate repair requests when necessary.
• Conduct routine inspections to ensure that the clean room and equipment meet quality standards.
• Document and report any deviations from the established quality parameters.
• Follow and enforce Good Manufacturing Practices (GMP) and other relevant industry regulations and standards.
• Aid in the development of work instructions and procedures.
• Assist in internal and external audits, as needed.
• Comply with all safety procedures and protocols.
• Identify and report safety hazards or concerns.
• Complete and/or participate in validation activities.
• Investigate any deviations in cleanroom operations

 

        Requirements:

• Experience supporting manufacturing and quality in a cleanroom environment
• Experience developing cleanroom and cleanroom product policies or specifications
• Excellent command of ISO and FDA requirements for medical product sterilization and cleanroom monitoring (ISO 11135, ISO 11137, ISO 14644, ISO 13485,etc)
• Experience with sterilization and process validations
• Good project management and report writing skills
• Good communication skills, both oral and written.
• Ability to manage multiple projects simultaneously

• Experience with attending ISO certification audits or FDA inspections to answer questions concerning cleanroom environment or sterilization
• Ability to work independently and adhere to timelines
• University Degree with a minimum of 5 years or related industry experience

 

        Physical Requirements:

                The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

• Regularly required to stand, walk, climb, stoop and crouch, push, pull, reach, grasp, feel, talk, and hear.
• Must be able to move around large areas
• Ability to stand for extended periods.
• Lift and carry up to 50 pounds.
• Wear appropriate personal protective equipment (PPE) as required.

 

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