B
Clean Rooms Lead / SME Consultant
Brooksource
Full-time
On-site
Wilson, NC, United States
Clean Room Lead - Pharmaceutical Industry
Wilson, NC (onsite)
Multi-year contract (W2 or 1099)
Overview:
We are seeking a highly experienced and detail-oriented Clean Room Subject Matter Expert /Lead to oversee the design, construction, and commissioning of clean room environments within pharmaceutical or life sciences facilities. The ideal candidate will have deep expertise in clean room standards, contamination control, HVAC systems, and regulatory compliance. This role is critical to ensuring that clean room construction and operation meet stringent industry and regulatory requirements, including GMP and ISO standards.
Key Responsibilities:
Assist EPCM Team with the planning, design review, and implementation of clean room environments in alignment with ISO 14644 standards and GMP/cGMP requirements.
Ensure clean room layouts, finishes, airflow, and pressure differentials meet regulatory and operational specifications.
Collaborate with engineering and construction teams to ensure design intent is maintained throughout the build process.
Oversee the construction and installation of clean room components including walls, ceilings, flooring, HVAC systems, HEPA filters, and pass-throughs.
Conduct inspections and audits to verify compliance with clean room construction standards and protocols.
Ensure proper installation and integration of clean room equipment and environmental monitoring systems.
Develop and implement contamination control strategies during construction and commissioning phases.
Coordinate with validation teams to ensure clean rooms are qualified for intended use.
Document and resolve any deviations or non-conformances during qualification.
Ensure all documentation complies with regulatory and company standards.
Act as the subject matter expert for clean room-related inquiries and troubleshooting.
Work closely with project managers, engineers, contractors, and QA teams to ensure project milestones are met.
Serve as the primary point of contact for clean room quality and compliance issues.
Required Skills & Qualifications:
Education: Bachelor's degree in Engineering, Construction Management, Microbiology, Industrial Hygiene, or a related field. Clean room certification (e.g., IEST, ISO) is highly desirable.
Experience:
10+ years of experience in clean room design, construction, and validation within pharmaceutical or life sciences environments.
Proven expertise in ISO 14644 standards, GMP/cGMP regulations, and contamination control.
Experience leading clean room projects from concept through commissioning.
Strong understanding of HVAC systems, airflow dynamics, and pressure balancing in controlled environments.
Excellent communication, leadership, and organizational skills.
Proficiency in quality management systems, document control platforms, and MS Office Suite.
Job Types: Full-time, Contract
Pay: From $100.00 per hour
Expected hours: 40 per week
Work Location: In person
Wilson, NC (onsite)
Multi-year contract (W2 or 1099)
Overview:
We are seeking a highly experienced and detail-oriented Clean Room Subject Matter Expert /Lead to oversee the design, construction, and commissioning of clean room environments within pharmaceutical or life sciences facilities. The ideal candidate will have deep expertise in clean room standards, contamination control, HVAC systems, and regulatory compliance. This role is critical to ensuring that clean room construction and operation meet stringent industry and regulatory requirements, including GMP and ISO standards.
Key Responsibilities:
Assist EPCM Team with the planning, design review, and implementation of clean room environments in alignment with ISO 14644 standards and GMP/cGMP requirements.
Ensure clean room layouts, finishes, airflow, and pressure differentials meet regulatory and operational specifications.
Collaborate with engineering and construction teams to ensure design intent is maintained throughout the build process.
Oversee the construction and installation of clean room components including walls, ceilings, flooring, HVAC systems, HEPA filters, and pass-throughs.
Conduct inspections and audits to verify compliance with clean room construction standards and protocols.
Ensure proper installation and integration of clean room equipment and environmental monitoring systems.
Develop and implement contamination control strategies during construction and commissioning phases.
Coordinate with validation teams to ensure clean rooms are qualified for intended use.
Document and resolve any deviations or non-conformances during qualification.
Ensure all documentation complies with regulatory and company standards.
Act as the subject matter expert for clean room-related inquiries and troubleshooting.
Work closely with project managers, engineers, contractors, and QA teams to ensure project milestones are met.
Serve as the primary point of contact for clean room quality and compliance issues.
Required Skills & Qualifications:
Education: Bachelor's degree in Engineering, Construction Management, Microbiology, Industrial Hygiene, or a related field. Clean room certification (e.g., IEST, ISO) is highly desirable.
Experience:
10+ years of experience in clean room design, construction, and validation within pharmaceutical or life sciences environments.
Proven expertise in ISO 14644 standards, GMP/cGMP regulations, and contamination control.
Experience leading clean room projects from concept through commissioning.
Strong understanding of HVAC systems, airflow dynamics, and pressure balancing in controlled environments.
Excellent communication, leadership, and organizational skills.
Proficiency in quality management systems, document control platforms, and MS Office Suite.
Job Types: Full-time, Contract
Pay: From $100.00 per hour
Expected hours: 40 per week
Work Location: In person