Cleanroom Contamination Control Engineer

Work Schedule

Environmental Conditions

Job Description

We are seeking an experienced Cleanroom Contamination Control Engineer to join our high-tech manufacturing team. The Cleanroom Contamination Control Engineer will be responsible for ensuring that all cleanroom operations comply with stringent contamination control standards. This role involves developing and implementing contamination control strategies, monitoring cleanroom environments, and collaborating with various departments to maintain the highest levels of cleanliness. This position acts as a key interface between Manufacturing, Quality, Facilities, and Supply Chain to maintain contamination control, optimize workflows, and support continuous improvement of cleanroom processes. The position combines hands-on operational support with engineering oversight of cleanroom performance, material flow, and personnel practices.

DESCRIPTION

How you will make an impact:

You will ensure reliable, compliant, and efficient operation of cleanroom environments while driving contamination control excellence across manufacturing operations.

What you will do:

Cleanroom Operations & Performance:

• Monitor and optimize daily cleanroom operations to ensure compliance with defined standards (e.g., ISO classifications, GMP where applicable)
• Support production teams in maintaining efficient workflows while minimizing contamination risks
• Investigate operational issues, including environmental excursions and process deviations
• Work closely with engineering, quality assurance, and production teams to ensure contamination control requirements are integrated into all aspects of cleanroom operations

Contamination Control:

• Develop and implement comprehensive contamination control plans and protocols for cleanroom environments
• Regularly monitor and audit cleanroom operations to ensure compliance with industry standards and company policies
• Analyze environmental monitoring (EM) data and identify trends or risks
• Drive root cause analysis and implement corrective and preventive actions (CAPA)

Facilities & Equipment Interface:

• Collaborate with Facilities/Engineering on HVAC performance, pressure cascades, and cleanroom qualification (IQ/OQ/PQ)
• Support maintenance planning to minimize operational disruption
• Participate in cleanroom design changes, expansions, and upgrades
• Oversee environmental monitoring programs, including particle counts and other contamination control metrics

Material & Personnel Flow:

• Design and improve material and personnel flows to ensure unidirectional movement and reduce cross-contamination
• Define and optimize gowning procedures and material entry/exit processes
• Partner with Supply Chain to ensure proper handling and availability of cleanroom materials
• Provide training and guidance to cleanroom personnel on contamination control best practices and procedures

Quality & Compliance:

• Ensure adherence to SOPs, regulatory requirements, and internal quality standards
• Own or contribute to change controls, deviations, and risk assessments
• Maintain detailed records of contamination control activities, audits, and incidents
• Prepare reports for management and regulatory bodies as required

Continuous Improvement:

• Identify opportunities to improve cleanroom utilization, throughput, and cost efficiency
• Lead or support Lean / Six Sigma initiatives within cleanroom operations
• Investigate contamination incidents, identify root causes, and implement corrective actions to prevent recurrence
• Implement digital tools (MES, EMS data analysis) to enhance monitoring and control

REQUIREMENTS

How you will get here:

Education:

• Bachelor's degree in Engineering (Mechanical, Chemical, Industrial, or related field), or equivalent experience

Experience:

• 4+ years of experience in cleanroom operations, contamination control, or manufacturing engineering
• Proven experience with ISO cleanroom classifications and environmental monitoring programs
• Experience with root cause analysis, CAPA, and change control processes

Skills and Knowledge:

• Strong understanding of contamination control principles and cleanroom operations
• Knowledge of HVAC systems, pressure cascades, and cleanroom qualification (IQ/OQ/PQ)
• Familiarity with GMP, SOPs, and regulatory compliance requirements
• Experience with Lean, Six Sigma, or other continuous improvement methodologies preferred
• Strong analytical skills with ability to interpret environmental monitoring data
• Excellent communication and cross-functional collaboration skills
• Ability to provide training and guidance to technical personnel