Quality Engineer I, Controlled Environments

Job Summary

To support a growing team, the full-time Quality Engineer I, Controlled Environments will provide engineering and technical support in Cleanroom Environmental Monitoring, Contamination Controls, and Microbiological Testing, ensuring compliance with industry standards while performing various testing and analysis tasks in a manufacturing environment.

Key responsibilities

• Develop and maintain a routine testing program for the manufacturing environment, including air pressure, temperature, and microbiological testing
• Ensure compliance with ISO standards and perform gap analysis for new/revised standards related to Controlled Environment and Contamination Control Programs
• Oversee and perform microbiological testing and data entry, as well as manage CAPA requests and related documentation

Required qualifications

• Bachelor's Degree in Engineering, Biology, Microbiology, Chemistry, or a related science, with two years of experience in a medical device or pharmaceutical environment
• Familiarity with ISO Standards for Controlled Environments and Microbiological Testing
• Ability to create and revise technical documentation with minimal guidance
• Strong organizational and negotiation skills
• Detail-oriented with a capability for self-review