Job Description

Job Summary:

The Cleanroom Engineer is responsible for the

design, construction, operation, cleaning, maintenance, validation, and classification

of cleanrooms and controlled environments as per

ISO 14644

standards and

Good Manufacturing Practices (GMP)

. This role ensures environmental control, cleanliness levels, and operational compliance of cleanrooms across lifecycle stages, supporting pharmaceutical, biotech, electronics, or medical device facilities.

Key Responsibilities:

1. Cleanroom Design & Build:

Design cleanrooms based on ISO 14644 classifications (e.g., ISO 5-8) and GMP requirements. Develop layouts, airflow models (unidirectional/non-unidirectional), pressurization, and filtration systems (HEPA/ULPA). Coordinate with architects, MEP engineers, and HVAC specialists. Supervise construction, commissioning, and qualification activities.

2. Cleaning & Contamination Control:

Develop and implement cleanroom cleaning protocols (daily, weekly, periodic). Select and validate cleaning materials (wipes, detergents, disinfectants). Train staff on gowning, hygiene, and cleaning SOPs. Ensure compliance with particle count and microbial contamination limits.

3. Maintenance & Facility Support:

Develop and execute preventive maintenance plans for cleanroom infrastructure. Oversee HVAC, pressure differentials, filter replacements, and utilities. Ensure continued qualification of equipment and facility integrity. Coordinate with validation and facility teams to minimize downtime.

4. Validation & Classification:

Plan and execute qualification phases: DQ, IQ, OQ, PQ. Conduct or supervise cleanroom classification tests: particle counting, airflow velocity, pressure differentials, recovery time. Ensure compliance with ISO 14644-1 and -3, GMP Annex 1, and customer-specific requirements. Maintain all validation documentation and records for audits.

5. Documentation & Compliance:

Develop and maintain SOPs for cleaning, maintenance, validation, and operation. Support internal and external audits and per countries regulations Ensure traceability and compliance with regulatory and ISO standards.

6. Subcontractor & Vendor Coordination:

Evaluate, select, and qualify subcontractors and vendors for cleanroom construction, HVAC systems, filtration units, cleaning services, and validation equipment. Develop scopes of work (SOW), technical requirements, and compliance guidelines for external partners. Coordinate timelines, deliverables, and project milestones with external service providers to ensure adherence to quality, ISO/GMP standards, and project budgets. Monitor subcontractor performance during construction, cleaning, or maintenance tasks to ensure conformance to cleanroom classification and regulatory expectations.

7. Supplier Management:

Source and manage suppliers of cleanroom materials (e.g., panels, HEPA filters, cleanroom consumables, monitoring devices). Ensure procurement of validated and certified materials aligned with ISO 14644 and GMP requirements. Work closely with procurement and quality teams to maintain supplier approval records and non-conformance handling.

8. Contractual & Compliance Oversight:

Ensure that subcontractors and suppliers follow site safety, security, documentation, and compliance procedures. Review and validate documentation from third parties, including material certificates, cleaning validation, test reports, and equipment calibration logs.

9. Budget & Cost Control:

Assist in budgeting project costs, service contracts, and equipment procurement related to external vendors. Review subcontractor invoices against work completion and deliverables for approval and reconciliation.

Qualifications:

Bachelor's degree in Mechanical Engineering, Industrial Engineering, HVAC, or related field. Professional certifications (e.g., CCE - Certified Cleanroom Engineer) are a plus. 3-5 years of experience in cleanroom design, build, or operations (ISO 14644/GMP environments). Working knowledge of HVAC, BMS, filtration systems, and cleanroom cleaning protocols.

Skills & Competencies:

Strong understanding of ISO 14644, GMP, and contamination control. Proficient in cleanroom design software (AutoCAD, Revit) and particle monitoring tools. Analytical, detail-oriented, and process-driven mindset. Strong communication skills and cross-functional coordination. Capable of preparing technical reports and SOPs.
Job Type: Full-time

Pay: AED2,500.00 - AED5,000.00 per month