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

For Microbiological Cleaning Validation Specialist services in the Microbiological area

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's degree in Microbiology, Biology, Biotechnology, Biomedical Sciences, or a related scientific discipline
• Five or more years of relevant experience in microbiology, contamination control, environmental monitoring, cleaning validation, or related quality functions within a regulated industry.
• Shift: Administrative and a ccording 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.
  • Supporting remediation programs, manufacturing transfers, regulatory inspections, or external audits.
  • Coordinating work performed by contract laboratories or other external service providers.

The Personality Part:

• If you have a commitment to serving customers with high-quality research and products, to embracing a diverse work culture, and even to the environment, you might just be what we’re looking for!
  

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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.
• Evaluate whether routine cleaning, equipment drying, storage, and sanitization practices adequately control microbial proliferation.
• Support microbiological evaluation of cleaning agents, sanitizers, and disinfectants proposed for controlled manufacturing environments or equipment surfaces.
• Review available supplier information, efficacy data, intended use, concentration, contact time, application method, and material-surface considerations.
• Support investigations involving cleaning failures, microbiological contamination, environmental excursions, atypical laboratory results, or validation deviations.
• Contribute microbiological expertise to root-cause analysis, product-impact assessment, risk assessment, nonconformance, CAPA, and change-control activities.
• Author or revise protocols, reports, procedures, work instructions, technical assessments, risk assessments, data summaries, and scientific rationales.
• Ensure deliverables follow approved templates, Good Documentation Practices, data-integrity expectations, and applicable document-control requirements.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!