Plant Engineering-Clean Room

Role:

Cleanroom Subject Matter Expert (SME)

Role Summary

We are looking for an experienced Cleanroom SME with 11 to 16 years of hands-on experience in cleanroom operations, compliance, monitoring and validation. The candidate should have strong technical expertise in ISO 14644 cleanroom standards, HVAC systems, airflow management, pressure cascades, AHU/FCU systems, HEPA/ULPA filtration and environmental monitoring. The role will act as a core Cleanroom Subject Matter Expert (SME), providing technical guidance for cleanroom operations, compliance, troubleshooting, validation and continuous improvement.

Key Responsibilities

1. Cleanroom Operations & Compliance

• Act as the core technical SME for cleanroom operations and compliance.
• Ensure cleanroom classification, monitoring and requalification are maintained in line with applicable ISO 14644 requirements.
• Establish, review and maintain cleanroom operating procedures and standards.
• Monitor cleanroom performance and ensure adherence to defined operational requirements.

2. HVAC & Cleanroom Technical Expertise

• Review and provide technical inputs on HVAC layouts, airflow patterns and pressure cascades.
• Evaluate cleanroom zoning, AHU/FCU design and performance.
• Ensure effective selection, monitoring and maintenance of HEPA/ULPA filtration systems.
• Identify technical deviations and coordinate corrective actions related to cleanroom HVAC performance.

3. Environmental Monitoring

• Establish and maintain cleanroom environmental monitoring systems.
• Monitor and analyse particle counts, differential pressure, temperature and relative humidity (RH).
• Review trends and identify deviations or abnormal conditions.
• Ensure appropriate corrective and preventive actions are initiated based on monitoring results.

4. Compliance, Audits & Validation

• Support and lead technical inputs for internal, customer and regulatory audits.
• Interpret compliance requirements and ensure alignment of cleanroom practices with applicable standards.
• Support cleanroom qualification and requalification activities.
• Review and maintain validation-related documents, SOPs and work instructions.

5. RCA & CAPA

• Lead technical investigations for cleanroom deviations and recurring issues.
• Conduct Root Cause Analysis (RCA) and identify appropriate corrective actions.
• Initiate and monitor CAPA implementation.
• Analyse cleanroom performance trends to identify potential risks and improvement opportunities.

6. Team & Stakeholder Management

• Provide technical guidance and mentoring to the cleanroom engineering/operations team.
• Conduct technical training and knowledge-sharing sessions on cleanroom practices and compliance.
• Coordinate with cross-functional teams for cleanroom-related activities and issue resolution.
• Ensure effective communication of technical requirements and compliance expectations across the team.

7. Documentation & Standardization

• Develop, review and maintain SOPs, Work Instructions, cleanroom monitoring records, validation documents, compliance documentation and RCA/CAPA records.
• Ensure documentation is accurate, current and audit-ready.

Core Technical Skills

ISO 14644 | Cleanroom Classification & Requalification | Cleanroom Compliance | Cleanroom HVAC | AHU / FCU | Airflow Management | Pressure Cascade | Cleanroom Zoning | HEPA / ULPA Filters | Particle Count Monitoring | Differential Pressure | Temperature & RH Monitoring | Environmental Monitoring | Cleanroom Validation | RCA | CAPA | SOP / Work Instructions | Audit & Compliance | Performance Trending

Preferred Candidate Profile

• 1116 years of relevant experience, with substantial experience specifically in Cleanroom operations/engineering.
• Should be a core Cleanroom SME, rather than a general facility/HVAC professional.
• Strong understanding of ISO 14644, cleanroom classification, monitoring and requalification.
• Strong practical knowledge of cleanroom HVAC, airflow, pressure cascade, AHU/FCU and HEPA/ULPA systems.
• Proven experience in RCA, CAPA, compliance, validation and audit support.
• Strong documentation, analytical and problem-solving skills.
• Experience in leading/mentoring technical teams and coordinating with cross-functional stakeholders.