QC Microbiologist II

Kindeva•Bridgeton, MO

1d•Onsite

About The Position

The QC Microbiologist II is a subject matter expert in aseptic processing, sanitization, microbiological quality standards, and related procedures at Kindeva’s aseptic plant in Bridgeton, Missouri. The role supports sterilization product and process validations, qualification of laboratory and production sterilization systems, Container Closure Integrity Testing, Biological Indicator Qualification, Sterility Testing, and other microbiological programs. The position performs microbiological validation of manufacturing processes and support systems; evaluates changes to approved aseptic manufacturing facilities and equipment; and prepares evaluations supporting microbiology and environmental monitoring programs. The colleague writes SOPs, qualification protocols, technical reports, and project plans, interprets data for accuracy, precision, trends, and potential GMP impact, and recommends or implements corrective actions as appropriate. Working under general supervision and established procedures, the colleague leads or oversees defined processes, contributes to team objectives and project milestones, drives continuous improvement, and maintains regulatory audit readiness. The role also performs qualitative and quantitative assays using standard microbiological equipment.

Requirements

Bachelor’s or master’s degree 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 communication, written communication, and interpersonal skills.
Basic computer literacy.
Ability to organize time independently and prioritize workload.
Technical knowledge of one or more microbiological disciplines: aseptic processing; environmental monitoring of a pharmaceutical cleanroom environment (viable and non-viable); sanitization; Biological Indicator Qualification; microbial enumeration testing or sterility testing; bacterial endotoxin testing; and/or microbial identification.

Nice To Haves

At least three years of prior experience in an industrial and/or aseptic pharmaceutical production environment is preferred.
Experience using Lean, Six Sigma, or other continuous improvement methodologies for process improvement is highly desirable.

Responsibilities

Demonstrate technical expertise in aseptic processing, sanitization, relevant principles and practices, and industry 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, Sterility Testing, and related activities.
Perform microbiological validation of manufacturing processes and support systems.
Evaluate changes in approved aseptic manufacturing facilities and equipment for conformance with 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 and contribute to team objectives and assigned project milestones.
Interpret and evaluate data for accuracy, precision, trends, and potential GMP impact; recommend and implement corrective actions when appropriate.
Perform qualitative and quantitative assays on samples using standard microbiological equipment.
Drive continuous improvement and maintain regulatory audit readiness for assigned programs.