Cleanroom Contamination Control Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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

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