Cleanliness and Contamination Control Manager

2 days ago


California MO United States Envista Full time


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
Critical Success Factors / Key Challenges:
  • 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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