We are seeking an accomplished and technically adept Director – Cleanroom and Environmental Systems to lead the strategic planning, design, implementation, and compliance of cleanroom facilities and environmental control systems. This role is critical in ensuring cleanroom performance, regulatory compliance, operational excellence, and future-ready infrastructure in industries such as pharmaceuticals, biotechnology, semiconductor manufacturing, aerospace, and advanced electronics.
The ideal candidate will possess deep technical knowledge of cleanroom classifications, HVAC design, contamination control, validation, and industry standards, coupled with strong leadership, project management, and cross-functional coordination capabilities.
Provide overall leadership and technical direction for cleanroom and environmental systems engineering and operations across multiple projects and facilities.
Develop strategic plans for cleanroom expansion, upgrades, sustainability improvements, and regulatory compliance.
Collaborate with senior executives, quality, R&D, and operations to align cleanroom infrastructure with business needs.
Lead the design, specification, and optimization of cleanroom facilities (ISO 14644, EU GMP, USP <797>/<800>, etc.).
Oversee the integration of HVAC systems, air handling units (AHUs), HEPA filtration, laminar flow, pressurization schemes, and humidity/temperature control.
Review and approve engineering documentation including design drawings, airflow schematics, room zoning, environmental monitoring systems (EMS), and utility layouts.
Ensure cleanrooms meet all applicable regulatory and industry standards (e.g., FDA, EMA, ISO 14644, cGMP, IEST, USP, GAMP).
Oversee qualification/validation processes including DQ/IQ/OQ/PQ, airflow visualization, particle counts, and recovery time testing.
Liaise with quality assurance, auditors, and regulatory agencies during inspections and audits.
Direct capital projects for new cleanroom builds or retrofits from concept through commissioning and handover.
Develop and manage budgets, schedules, risk plans, and resource allocation for cleanroom projects.
Coordinate across disciplines (architecture, HVAC, electrical, controls, process engineering, QA) to deliver high-quality facilities.
Monitor ongoing cleanroom performance, maintenance, and environmental conditions to ensure continuous compliance.
Drive improvements in reliability, energy efficiency, and contamination control practices.
Establish SOPs, preventive maintenance plans, and staff training programs related to cleanroom operation and response protocols.
Build and lead a high-performing team of engineers, validation specialists, and project managers.
Provide mentorship, career development, and performance management for direct reports.
Promote a culture of technical excellence, safety, and continuous improvement.
Education:
Bachelor’s degree in Mechanical Engineering, Environmental Engineering, Industrial Engineering, or related field (Master’s preferred).
Professional certifications (e.g., PMP, ASHRAE membership, CCE, or LEED AP) are advantageous.
Experience:
10+ years of relevant experience in cleanroom design, HVAC/environmental systems, and facilities management.
Proven track record of leading cleanroom projects in regulated environments such as pharma, biotech, semiconductor, or aerospace.
Deep understanding of airflow dynamics, particulate control, cleanroom behavior, and HVAC system integration.
Technical Skills:
Strong knowledge of ISO 14644, EU GMP Annex 1, FDA cGMP, USP <797>/<800>, IEST, ASHRAE, and other relevant standards.
Proficiency with cleanroom design and simulation tools (AutoCAD, Revit, CFD tools, airflow modeling software).
Familiarity with EMS/BMS systems, HVAC controls, and cleanroom commissioning tools.
Executive-level leadership with strong communication and presentation skills
Deep technical expertise in cleanroom systems and compliance
Project and budget management proficiency
Cross-functional team leadership and stakeholder engagement
Commitment to quality, safety, and operational excellence