Cleanliness and Contamination Control Manager

About the role

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

Responsibilities

• 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.

Qualifications

• 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
• Preferred 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

Skills

• 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

Pay

$105,200 - $128,600

Benefits

• Annual performance bonus
• Medical/dental/vision benefits
• 401K match
• Other applicable compensation plans