Senior Sterilization Expert

6 days ago


Racine, Wisconsin, United States Merz North America Full time

About Merz North America:
Merz North America is a leading medical device and pharmaceutical company based in the United States. Our team of experts is dedicated to delivering high-quality products that improve patient outcomes.

Job Summary:
We are seeking a highly skilled Senior Sterilization Expert to join our team at Merz North America. As a key member of our quality assurance department, you will be responsible for ensuring the sterilization processes meet the highest standards of quality and safety.

Responsibilities:
* Develop and maintain site level microbiological testing programs, including test method development, validation, and implementation* Evaluate and implement new microbiology technologies per Quality System Standards and regulations* Write, revise, and review related Standard Operating Procedures (SOPs) and Department related Protocols* Establish and maintain site microbiological and contamination control programs, including employee training* Conduct daily operations for a team of microbiologists and coordinate with other departments as needed* Qualify and maintain the qualification of quality assurance activities associated with the sterilization of products* Maintain risk assessments required for parametric release* Perform quality reviews of microbiological testing and EM monitoring data* Identify and communicate adverse trends in routine microbiological monitoring* Lead laboratory root cause analysis investigations and implement corrective actions* Participate in internal and external audits* Support facilities and manufacturing teams to ensure compliance to sterilization, product, process, environmental, and cleaning requirements

Requirements:
* Bachelor's degree in Microbiology, Biology, or Physical Science; Master's degree preferred* At least 8 years of experience in Pharmaceutical/Medical Device Microbiological Quality/Sterility Assurance; GLP/GMP experience required* Strong technical and general problem-solving skills* Aseptic technique and understanding of microbiology; experience in training personnel a plus* Familiarity with ISO 13485 Quality System Standards, ISO 14644 Cleanrooms, and international medical device regulations* Knowledge of manufacturing and quality assurance activities associated with the sterilization of medical devices* Experience with sterilization processes (Steam, EtO, Gamma) and testing methods* Ability to work effectively with cross-functional teams and communicate complex information to stakeholders

Benefits:
* Competitive salary: $110,000 - $140,000 per year* Comprehensive medical, dental, and vision plans* 20 days of paid time off, 15 paid holidays, paid sick leave, and parental leave* 401(k) plan with company match* Employee bonuses and opportunities for professional growth and development* Equal opportunity employer committed to diversity and inclusion

Contact Information:
Please submit your application through our website.



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