Job Summary
Our organization seeks a seasoned contamination control professional to oversee global cleanroom operations and processes across sterile and non-sterile sites. This role requires strategic leadership, technical expertise, and effective collaboration with cross-functional teams.
Key Responsibilities
* Develop and implement cleanroom design strategies in compliance with ISO and GMP standards
* Design and optimize monitoring programs; analyze data and ensure corrective actions are taken
* Establish and enforce gowning protocols for sterile and non-sterile environments
Requirements
Candidates must hold a Master's degree in microbiology, biotechnology, engineering, or a related field and possess at least 5 years of experience in cleanroom management and/or environmental monitoring in the pharmaceutical industry or a related field.
Applicants should also have experience in GMP-compliant process design/management as well as knowledge of ISO standards, GMP regulations, and regulatory requirements.
Skills and Qualifications
* Technical expertise in contamination control and cleanroom operations
* Strategic leadership and project management skills
* Effective communication and collaboration skills
* Strong analytical and problem-solving skills
* Knowledge of relevant regulations and standards