Cleanroom Compliance Engineer

Your Job

At Phillips Medisize our Cleanroom Compliance Engineer plays a critical role in ensuring compliance with environmental quality standards across our manufacturing and laboratory sites.

This position involves managing routine and non-routine environmental testing, supporting facility validations, and driving continuous improvement efforts to maintain hygienic compliance and cleanroom certifications.

As a key member of the quality and validation team, you will also support succession planning and partner with cross-functional teams on environmental monitoring and quality systems.

This role will be based in Hudson, Wisconsin with support responsibilities across multiple sites including Hudson, New Richmond and Menomonie, WI.

Some travel may be required.

Our Team

We empower every team member to contribute to quality in every process, ensuring that environmental conditions consistently meet or exceed regulatory and customer expectations.

Our Cleanroom Compliance Engineer's expertise supports robust controls that protect product integrity and patient safety.

What You Will Do



* Provide direction and guidance for cleanroom certification, operation, and maintenance in accordance with ISO 14644 and internal standards


* Maintain and develop laboratory spaces for environmental microbial testing, including plans for future Blink micro-labs


* Ensure GMP compliance for drug handling cleanrooms and locations , including adherence to cleaning procedures and good hygienic practices


* Learn from senior SMEs and become an additional subject matter expert supporting process owner tasks, micro audits, hygienic compliance, cleaning procedures/validations, facility design, and HVAC


* Lead environmental test equipment qualifications, and environmental process failure mode and effects analysis (pFMEAs).

Technical input to facility validations


* Own and drive site-level and divisional quality notifications (QNs) and environmental reports (ERs), including failure communications and issue escalation


* Partner with Quality Training Managers to improve or create GMP training programs related to environmental quality


* Potentially manage technician(s) responsible for routine and non-routine environmental testing

Who You Are (Basic Qualifications)



* Experience in environmental quality, cleanroom certification, or containment testing


* Familiarity with ISO 14644, ISO 8573, GMP requirements, and environmental microbial monitoring


* Proven ability to organize and manage multiple priorities simultaneously


* Experience training and collaborating effectively with cross-functional teams


* Experience with problem-solving and driving continuous improvement initiatives

What Will Put You Ahead



* Experience in pharmaceutical or regulated manufacturing environmental quality


* Knowledge of gas sampling, and lighting testing


* Experience working with HVAC systems and facility design for cleanro...