Senior Microbiologist Specialist
About The Position
This role is for a Senior Microbiologist Specialist in the Laboratory area. The ideal candidate will have a 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. The position involves administrative duties and is according to business needs. The role requires experience in ISO Class 8 cleanrooms, environmental testing (BET, Bioburden, Air, Surface, etc.), conducting complex investigations (OOS results, environmental excursions, adverse trends, root cause analysis, CAPA implementation), and authoring/executing qualification/requalification protocols, developing technical reports, and ensuring compliance with FDA regulations, ISO 14644, ISO 13485, and ISO 11737 standards. The company culture emphasizes treating everyone like family, strong customer service, innovation, and delivering top-quality results.
Requirements
- Bachelor's degree in Microbiology, Biology, Science, or a related scientific discipline (highly preferred Microbiology)
- At least ten (10) years of experience in microbiological testing, environmental monitoring, and contamination control within regulated pharmaceutical and medical device manufacturing environments.
- Experience in ISO Class 8 cleanrooms.
- Experience in 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.
- Experience authoring and executing qualification/requalification protocols.
- Experience developing technical reports.
- Ensuring compliance with FDA regulations, ISO 14644, ISO 13485, and ISO 11737 standards.
Nice To Haves
- Treats everyone they meet like family, especially resources, clients and team members.
- Customer service skills.
- Full of bright ideas and eager to innovate.
- Always bringing top-quality results to the table.
Responsibilities
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
