QC Microbiologist II
About The Position
Kindeva is hiring a Microbiologist for its state-of-the-art aseptic plant in Bridgeton, Missouri. The role provides subject matter expertise in standard operating procedures and quality standards, and supports sterilization product and process validations, qualification of laboratory and production sterilization systems, Container Closure Integrity Testing, Biological Indicator Qualification, and Sterility Testing. The position performs microbiological validation of manufacturing processes and support systems, evaluates changes to approved aseptic manufacturing facilities and equipment against microbiological quality standards, and prepares evaluations supporting microbiology and environmental monitoring programs. It also develops SOPs, qualification protocols, technical reports, and project plans, while leading or overseeing defined processes. The Microbiologist interprets data for accuracy, precision, trends, and potential GMP impact; recommends and implements corrective actions when needed; and performs qualitative and quantitative assays using standard microbiological equipment. Working under general supervision and established procedures, the colleague contributes to team objectives and project milestones, drives continuous improvement, and maintains regulatory audit readiness.
Requirements
- BS or MS in Microbiology, Bacteriology, or a related biological science.
- Understanding of aseptic laboratory techniques.
- Three to five years of experience in microbiological process control functions and total particulate monitoring in a cleanroom environment.
- Good planning, oral, written, and interpersonal communication skills.
- Basic computer literacy and ability to organize time independently and prioritize workload.
- Technical knowledge in one or more microbiological disciplines, such as aseptic processing, pharmaceutical cleanroom environmental monitoring (viable and non-viable), sanitization, Biological Indicator Qualification, Microbial Enumeration Testing, Sterility Testing, Bacterial Endotoxin Testing, or Microbial Identification.
Nice To Haves
- At least three years of experience in an industrial and/or aseptic pharmaceutical production environment (preferred).
- Experience using Lean, Six Sigma, or other continuous improvement methodologies for process improvement (highly desirable).
Responsibilities
- Apply technical expertise in aseptic processing, sanitization, microbiological principles, concepts, and industry practices and standards.
- Provide subject matter expertise for standard operating procedures and quality standards content.
- Support sterilization product and process validations and qualification of laboratory and production sterilization systems.
- Support Container Closure Integrity Testing, Biological Indicator Qualification, and Sterility Testing.
- Perform microbiological validation of manufacturing processes and support systems.
- Evaluate changes in approved aseptic manufacturing facilities and equipment for conformance to microbiological quality standards.
- Write evaluations supporting microbiology and environmental monitoring programs.
- Write SOPs, qualification protocols, technical reports, and project plans; lead or oversee defined processes.
- Interpret and evaluate data for accuracy, precision, trends, and potential GMP impact, and recommend and implement corrective action as necessary.
- Perform qualitative and quantitative assays on samples using standard microbiological equipment.
- Contribute to team objectives and assigned project milestones.
- Drive continuous improvement and maintain regulatory audit readiness for assigned programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
