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Validation Engineer
Ref No.: 18-13114
Location: Marion, North Carolina
Start Date: 10/04/2018
Description:

Test Method Validation: Microbiologist (Swab Method Validation and Recovery)
• Count colony forming units (CFU) on Petri plates.
• Perform Growth Promotion and inoculum cultures
• Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.
• Maintain accurate and complete test records.
• Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
• Maintain current knowledge of regulatory and industry standards, trends and advancements.
• Conduct method development, method validation and method transfer
• Demonstrates proficient support in swab recovery studies
• Supports activities regarding audits of suppliers and contract labs in support of vendor certification program.
• Conducts statistical evaluation of the data
• Ensures control of laboratory documentation (Raw Material COA, testing instructions, testing.
Education:
• Bachelor's degree in Microbiology, or closely related scientific discipline.
• Degree in Microbiology is highly preferred.
Experience:
• Laboratory experience is preferred.
• Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience.
• Microbiology laboratory skills and knowledge, such as aseptic techniques, is required.
• Demonstrated understanding of cGMPs, cGLPs, FDA regulations, and industry guidelines, as well as international regulatory guidelines.
• Ability to keep neat, accurate and complete records and logs.
• Must be proactive, results oriented, with a strong attention to detail.
• Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
• Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
• Strong organizational, analytical, troubleshooting and problem-solving skills.
• Ability to analyze details and perform structured decision-making on a daily basis.
• Excellent verbal and written communication.
• Must be able to read, write, and speak English.
• Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Physical Requirements:
• Requires long hours on standing at work bench or in a flow hood.