Microbiological Cleaning Validation Specialist

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.
• Bilingual: English & Spanish.
• 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.
  • 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 company different 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 industry clients with top-notch quality talent. We're FITS! 

Are you the Next Piece?