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Phillips Medisize · 7 hours ago

Cleanroom Compliance Engineer

Hudson, WI

Full-time

Onsite

Mid Level

Phillips Medisize is a company that collaborates with industry leaders to design and manufacture drug delivery systems and medical devices. The Cleanroom Compliance Engineer plays a critical role in ensuring compliance with environmental quality standards, managing environmental testing, supporting facility validations, and driving continuous improvement efforts to maintain cleanroom certifications.

Health CareHealth DiagnosticsManufacturingOutsourcing

No H1B

Responsibilities

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

Qualification

Cleanroom certificationISO 14644GMP complianceEnvironmental microbial monitoringHVAC systemsContinuous improvementTraining experienceCross-functional collaborationProblem-solving

Required

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

Preferred

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

Benefits

Medical

Dental

Vision

Flexible spending and health savings accounts

Life insurance

ADD

Disability

Retirement

Paid vacation/time off

Educational assistance

Infertility assistance

Paid parental leave

Adoption assistance

Company

Phillips Medisize

As a contract development and manufacturing organization (CDMO), the world’s leading pharmaceutical, medtech and in vitro diagnostic companies trust us to help them design and manufacture their products.

Founded in 1964