Senior Microbiologist Specialist

For Senior Microbiologist Specialist services in the Laboratory area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's degree in Microbiology, Biology, Science, or a related scientific discipline (highly preferred Microbiology) and at least ten (10) years of experience in microbiological testing, environmental monitoring, and contamination control within regulated pharmaceutical and medical device manufacturing environments. 
• Shift: Administrative and according to business needs. 
• Experience in:
  • ISO Class 8 cleanrooms.
  • Environmental testing (BET, Bioburden, Air, Surface, etc.).
  • Extensive experience conducting complex investigations, including OOS results, environmental excursions, adverse trends, root cause analysis, and CAPA implementation.
  • Authoring and executing qualification/requalification protocols, developing technical reports, and ensuring compliance with FDA regulations, ISO 14644, ISO 13485, and ISO 11737 standards.

The Personality Part:    

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

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

• Lead and support investigations (ex. OOS, environmental excursions, adverse trending, etc.).
• Write protocols and reports (Qualifications and Re-qualifications, ex.  Clean Rooms & Equipment).
• Create / Revise Laboratory procedures.
• Prepare and approve technical reports documenting investigation findings, qualification activities, and corrective actions.
• Monitor and evaluate environmental monitoring programs, including air sampling, surface monitoring, bioburden testing, and Bacterial Endotoxin Testing (BET).
• Analyze microbiological and environmental data to identify trends, assess risks, and recommend corrective and preventive actions (CAPAs).
• Create, revise, and maintain microbiology laboratory procedures, standard operating procedures (SOPs), and testing methodologies.
• Serve as the subject matter expert (SME) for microbiological compliance and contamination control within ISO Class 8 cleanroom environments.
• Ensure compliance with FDA regulations and applicable standards, including ISO 14644, ISO 13485, and ISO 11737.
• Provide technical guidance and mentorship to laboratory personnel, supporting best practices in microbiological testing and aseptic operations.
• Support internal audits, regulatory inspections, and quality system initiatives by providing documentation, investigation support, and microbiological expertise.

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!