Lead Microbiological Cleaning Validation Specialist

FITS, LLC; Dorado (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS is seeking a Microbiological Cleaning Validation Specialist to support cleaning validation and verification across regulated manufacturing environments in the US/PR region. You will contribute microbiological expertise to study design, data interpretation, and risk assessment, and coordinate with Operations, Quality, and external laboratories to ensure compliant documentation and timely deliverables.

The role demands a strong background in microbiology within medical device, pharma, or

Qualifications

• Bachelor's degree in Microbiology or a related scientific discipline.
• Five or more years of relevant experience in microbiology, contamination control, environmental monitoring, cleaning validation, or related quality functions in a regulated industry.
• Shift: Administrative and according to business needs.
• Experience in medical device, pharmaceutical, biotechnology, biologics, or combination-product manufacturing.
• Cleaning-validation lifecycle management, recovery studies, hold-time assessments, environmental monitoring trending, or disinfectant effectiveness studies.
• Coordinating work performed by contract laboratories or other external service providers.

Responsibilities

• Support the development, revision, execution, and closure of cleaning validation and cleaning verification protocols, reports, and supporting records.
• Provide microbiological input to sampling plans, sampling locations, sample collection methods, recovery studies, and acceptance criteria.
• Evaluate equipment configuration, product-contact surfaces, cleaning methods, storage conditions, and hold times for potential microbiological risk.
• Coordinate study execution with Operations, Engineering, Quality, and internal or external laboratories.
• Review study data for completeness, accuracy, traceability, and conformance with approved protocol requirements.
• Support periodic review, continued monitoring, requalification, and change-impact assessments for validated cleaning processes.
• Assess microbiological risks associated with equipment, manufacturing areas, cleaning practices, materials, utilities, and product-contact surfaces.
• Support development or improvement of contamination-control strategies and preventive controls.

Skills

Five+ years microbiology experience

Education

Bachelor's degree in Microbiology or related scientific discipline

Job description

FITS is seeking a Microbiological Cleaning Validation Specialist to support cleaning validation and verification across regulated manufacturing environments in the US/PR region. You will contribute microbiological expertise to study design, data interpretation, and risk assessment, and coordinate with Operations, Quality, and external laboratories to ensure compliant documentation and timely deliverables.

The role demands a strong background in microbiology within medical device, pharma, or