FITS, LLC
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Cleanroom Expert
role at
FITS, LLC
The role involves working as a Cleanroom Expert within the pharmaceutical industry, ensuring compliance with GMP, ISO, and FDA regulations.
Qualifications
Bachelor’s degree in Life Sciences or Engineering and eight (8) years of exposure to Project Services activities within the Pharmaceutical industry.
Shift: Administrative and according to business needs.
Bilingual: (Spanish and English).
Experience in Cleanroom SME in pharmaceutical or biotech facilities.
Strong knowledge of cleanroom technologies, including HVAC, HEPA/ULPA filtration, airflow patterns, and environmental monitoring.
Experience supporting CQV activities.
Responsibilities
Provide technical expertise on cleanroom design, construction, and operation in compliance with GMP, ISO, and FDA regulations.
Support HVAC systems, airflow visualization (smoke studies), pressure cascades, temperature and humidity control.
Review and approve cleanroom layouts, materials, finishes, and utility interfaces.
Oversee cleanroom installation activities during construction to ensure compliance with specifications.
Support commissioning, qualification, and validation (IQ/OQ/PQ) of cleanroom systems.
Collaborate with Engineering, CQV, Quality, and Construction teams.
Identify risks and implement corrective actions related to contamination control.
Ensure alignment with regulatory expectations.
Personality
Treat everyone like family; customer service pro; innovative and results-focused.
Company Overview We are a service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and the US. We are flexible, family-oriented, and focused on the well-being of our resources.
Referrals increase your chances of interviewing at FITS, LLC by 2x.
#J-18808-Ljbffr
Cleanroom Expert
role at
FITS, LLC
The role involves working as a Cleanroom Expert within the pharmaceutical industry, ensuring compliance with GMP, ISO, and FDA regulations.
Qualifications
Bachelor’s degree in Life Sciences or Engineering and eight (8) years of exposure to Project Services activities within the Pharmaceutical industry.
Shift: Administrative and according to business needs.
Bilingual: (Spanish and English).
Experience in Cleanroom SME in pharmaceutical or biotech facilities.
Strong knowledge of cleanroom technologies, including HVAC, HEPA/ULPA filtration, airflow patterns, and environmental monitoring.
Experience supporting CQV activities.
Responsibilities
Provide technical expertise on cleanroom design, construction, and operation in compliance with GMP, ISO, and FDA regulations.
Support HVAC systems, airflow visualization (smoke studies), pressure cascades, temperature and humidity control.
Review and approve cleanroom layouts, materials, finishes, and utility interfaces.
Oversee cleanroom installation activities during construction to ensure compliance with specifications.
Support commissioning, qualification, and validation (IQ/OQ/PQ) of cleanroom systems.
Collaborate with Engineering, CQV, Quality, and Construction teams.
Identify risks and implement corrective actions related to contamination control.
Ensure alignment with regulatory expectations.
Personality
Treat everyone like family; customer service pro; innovative and results-focused.
Company Overview We are a service provider company that integrates Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island and the US. We are flexible, family-oriented, and focused on the well-being of our resources.
Referrals increase your chances of interviewing at FITS, LLC by 2x.
#J-18808-Ljbffr