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.
Are you the Next Piece?
