The posting
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make This is an exciting opportunity at our state-of-the-art aseptic plant in Bridgeton, MO! As a Microbiologist this individual will be the subject matter expertise for standard operating procedures and quality standards content. Support and expertise in sterilization product/process validations, qualification of laboratory and production sterilization systems, Container Closure Integrity and more.
Hours: 2nd Shift (2 PM – 10:30 PM) - Training hours for 2-3 months – 8 AM – 5 PM
Responsibilities:
Will display technical expertise of Aseptic Processing and Sanitization as well as proper techniques, principles, theories, concepts and industry practices/standards. Provide subject matter expertise for standard operating procedures and quality standards content. Support and expertise in sterilization product/process validations, qualification of laboratory and production sterilization systems, Container Closure Integrity Testing, Biological Indicator Qualification, Sterility Testing, etc. Performs microbiological validation of manufacturing process and support systems. Evaluates changes in approved aseptic manufacturing facilities and equipment for conformance to microbiological quality standards. Writes evaluations to support microbiology and environmental monitoring programs. Writes SOP’s, qualification protocols, technical reports, project plans, etc. Focuses on leading/overseeing defined processes. Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact, recommends and implements appropriate corrective action where necessary. Performs qualitative and quantitative assays on samples using varying standard microbiological equipment. Works under general supervision, referring to policies and practices for guidance and follows established procedures. Operates within established HR policies and basic colleague relations guidelines. Contributes to the completion of specific team objectives and assigned project milestones. The colleague will be required to drive continuous improvement and maintain a state of regulatory audit readiness over these programs. Demonstrates knowledge and leadership principles. Will provide subject matter expertise for standard operating procedures and quality standards content. Support and expertise in sterilization product/process validations, qualification of laboratory and production sterilization systems, Container Closure Integrity Testing, Biological Indicator Qualification, Sterility Testing, etc. Performs microbiological validation of manufacturing process and support systems. Evaluates changes in approved aseptic manufacturing facilities and equipment for conformance to microbiological quality standards. Writes evaluations to support microbiology and environmental monitoring programs. Writes SOP’s, qualification protocols, technical reports, project plans, etc. Focuses on leading/overseeing defined processes. Interprets and evaluates data in terms of accuracy, precision, trends and potential GMP impact, recommends and implements appropriate corrective action where necessary. Performs qualitative and quantitative assays on samples using varying standard microbiological equipment. Works under general supervision, referring to policies and practices for guidance and follows established procedures. Operates within established HR policies and basic colleague relations guidelines. Contributes to the completion of specific team objectives and assigned project milestones. The colleague will be required to drive continuous improvement and maintain a state of regulatory audit readiness over these programs. Demonstrates knowledge and leadership principles
Qualifications:
BS/MS in Microbiology, Bacteriology or related biological science is required. Understanding of aseptic laboratory techniques is required. Minimum of three (3) years of previous experience in industrial and/or aseptic pharmaceutical production environment preferred. Three to five years of previous experience in microbiological process control functions and total particulate monitoring in a cleanroom environment. Possess good planning skills, good oral, written and interpersonal communication skills, and basic computer literacy and demonstrate the ability to organize time independently and prioritize workload. Possess 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. Experience utilizing Lean, Six Sigma and other continuous improvement methodologies for process improvement is highly desirable.
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