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)

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 cleanrooms
• 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.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Hiring Philosophy

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000 employees in 29 locations around the world, we share our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world's largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Our Benefits

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.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Equal Opportunities

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 click here for additional information. (For Illinois E-Verify information click here, aqui, or tu).

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