Cleanliness and Contamination Control Manager
2 days ago
Job Description:
The Cleanliness and Contamination Control Manager is responsible for ensuring cleanliness control and contamination control at the manufacturing site.
The Cleanliness and Contamination Control Manager is responsible to:
- Define and maintain contamination control and cleanliness control strategies.
- Drive improvements to enhance cleanliness control, including cleanroom setup, product final cleaning, tool cleaning, hygiene, and rules of conduct.
- Create/update procedures for cleanliness and contamination control and ensure they are adhered to.
- Ensure compliance with Quality Regulations, ISO, AAMI standards, and regional requirements.
- Lead investigations of monitoring excursions, contamination incidents, and deviations from contamination and cleanliness control procedures.
- Ensure monitoring related contamination and cleanliness control is performed.
- Analyze and interpret contamination control and cleanliness monitoring data, identifying trends and implementing corrective actions.
- Act as a Cleanliness and Contamination Control Subject Matter Expert (SME) during routine operations and audits.
Job Requirements:
Required:
- Bachelor’s degree in a relevant scientific discipline (preferably in microbiology)
- 2+ years of experience in the field of contamination control in the medical device or pharmaceutical industry
- Must reside within a commutable distance to Yorba Linda, CA.
Critical Skills/technical know-how:
- ISO 13485 (Quality Management System for Medical Devices)
- Sterilization (ISO 11137-1&2)
- Analytical Methods (ISO 11737-1,2,3)
- Clean room & Utilities (ISO 14644, ISO 14698, ISO 8573 series)
- ISO 10993-1
- Solid knowledge of regulatory requirements related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision.
- Solid expertise in statistical data analysis
- Good interpersonal skills with ability to work effectively with other groups
- Excellent verbal & written communication skills
- Strong interpersonal skills with a high level of accurateness, integrity, commitment, ethics and proactivity to cultivate a network of productive relationships in an international matrix environment
- Strong organizational and multitasking skills with the ability to prioritize tasks independently to meet the objectives of multiple projects simultaneously
- Strong analytical skills and result orientation
- Analyzes issues and breaks them down. Makes documented, systematic and rational judgments based on relevant information
- Fluency in English and the local language is mandatory, other languages are welcome
- Sound SAP system understanding
- Project management, multilayered project management, networking
- Beneficial comprehensive experience of manufacturing process needs to meet cleanliness requirements
- Experience in working in a highly ambiguous matrix organization
- Able to drive improvement projects simultaneously
- Able to implement clear procedures that describe processes adequately and are regulatory compliant as well as efficient use of resources
- Able to assess the impact of manufacturing changes (e.g., equipment, process, material, and environmental changes) on contamination and cleanliness control
- Author, revise, and review technical and procedural documentation related to contamination and cleanliness control practices
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