Cleanliness and Contamination Control Manager

The Cleanliness and Contamination Control Manager is an individual contributor and responsible for ensuring cleanliness and contamination control at the manufacturing site.

• 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.

• Bachelor’s degree in a relevant scientific discipline; Microbiology or Biology is a plus
• 2+ years of experience in the field of contamination control; medical device or pharmaceutical experience is required
• Solid knowledge of regulatory requirements related to contamination control and cleanliness control or ability to rapidly develop expertise to function independently with minimal supervision.
• ISO 13485 experience (QMS for pharma or medical device)
• ISO 11137 - 1&2 sterilization experience (Gamma irradiation)
• ISO 14644, ISO 14698, ISO 8573 series experience required (Clean room & utilities)
• ISO 10993-1 required (standard for evaluating the biological safety of medical devices within a risk management process)
• Solid expertise in statistical data analysis
• Project management experience
• ERP experience; SAP is a plus

• Analytical Methods preferred (ISO 11737-1,2,3)
• Comprehensive experience of manufacturing process needs to meet cleanliness requirements is a plus
• Experience in working in a highly ambiguous matrix organization is a plus
• 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