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 skilled.
- 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.

📌 Plant Engineering-Clean Room (Kanchipuram)
🏢 Motherson
📍 Kanchipuram