Contamination Control and Sterility Assurance Sr. Specialist
Cytiva
Duncan, SC
14 days ago
Job Description
At Cytiva, we are seeking a Senior Specialist for Contamination Control and Sterility Assurance to lead sterility assurance programs and enhance contamination control strategies. Join us to make a significant impact in life sciences and biotechnology by improving human health through innovative solutions.
Key Responsibilities
Responsible for the sterility assurance program at site level
Monitor and evaluate sterility assurance and contamination control performance
Analyze data and utilize statistical tools to assess process performance
Support non-conformance, investigations, CAPAs, and change control processes
Ensure compliance with regulatory requirements and industry standards for sterility and contamination control
Required Qualifications
Bachelor’s degree in microbiology, biology, pharmaceutical sciences, or a related field
Minimum of 5 years of experience in contamination control and sterility assurance within the pharmaceutical, biotechnology, or medical device industries
In-depth knowledge of regulatory requirements and industry standards for sterility assurance and contamination control (e.g., FDA, EMA, ISO)
Proven experience in developing and implementing sterility assurance programs and contamination control strategies
Strong analytical and problem-solving skills
Preferred Qualifications
Previous experience in Sterilization Standards and Regulations