Contamination Control Specialist Job Description
A Contamination Control Specialist is required to drive sterility assurance initiatives and ensure the highest levels of contamination control in a sterile manufacturing environment.
Key Responsibilities:
* Develop and implement comprehensive sterility assurance frameworks, including contamination control strategies aligned with regulatory guidelines.
* Conduct risk assessments for aseptic processes, environmental monitoring, and container closure systems to mitigate contamination risks.
* Lead initiatives to continuously improve aseptic techniques, gowning practices, and operational controls in sterile manufacturing environments.
Requirements:
* Bachelor's degree in Microbiology, Biotechnology, or a related discipline.
* Minimum 24 years of experience in sterility assurance or aseptic manufacturing.
* Strong understanding of Annex I, US, and EMA GMP regulations.
Benefits:
This role offers a unique opportunity to establish a robust sterility assurance culture, ensuring patient safety through the highest levels of contamination control, process integrity, and regulatory compliance.
Leadership Skills:
* Mentor and develop teams.
* Lead investigations.
* Drive sterility assurance initiatives.
Aseptic Process Expertise: Proven experience in contamination control strategies, including cleaning and disinfection validation.
Risk Assessment & Problem-Solving: Experience in sterility-related risk assessments, deviation investigations, and implementing corrective/preventive actions.
Communication & Collaboration: Excellent ability to articulate sterility assurance concepts and collaborate cross-functionally to drive compliance and process improvements.
This role requires a strong technical background in microbiology, biotechnology, or a related field, along with extensive experience in sterility assurance and aseptic manufacturing. The ideal candidate will have a proven track record of leading sterility assurance initiatives and driving contamination control strategies.