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.

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.

• 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 clean rooms 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). Provide 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

• 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

• Experience in pharmaceutical or regulated manufacturing environmental quality
• Knowledge of gas sampling and lighting testing
• Experience working with HVAC systems and facility design for clean rooms
• Familiarity with pest control programs and environmental lab management
• Previous experience in delivering GMP training programs and supporting hygienic compliance

This role is not eligible for VISA Sponsorship.

Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength – focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance.

Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.

Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E‑Verify. Please  for additional information. (For Illinois E‑Verify information , aqui, or tu).