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FDA Pharma Experience Engineer
(Jobs in Marion, NC)
 
Requirement id 90564
Job title Engineer
Job location in Marion, NC
Skills required Verbal Communication, Bachelor Degree In Computer Science, FDA, Pharma Experience
Open Date 29-Mar-2019
Close Date
Job type Contract
Duration 6 Months
Compensation DOE
Status requirement ---
Job interview type ---
   Email Recruiter: coolsoft
Job Description Engineer: Verbal Communication, Bachelor Degree In Computer Science, FDA, Pharma Experience

Description: Description:

Test Method Validation Professional with experience as a Microbiologist focused on Swab Method Validation and Recovery

Responsibilities:
Count colony forming units (CFU) on Petri plates.
Conduct method development, method validation and method transfer
Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples.
Perform Growth Promotion and inoculum cultures
Perform preparation of reagents, materials, and equipment used in microbiological testing in sterile environments, such as HEPA hoods.
Demonstrates proficient support in swab recovery studies
Maintain accurate and complete test records.
Maintain current knowledge of regulatory and industry standards, trends and advancements.
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.)
Qualifications:
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.
Education / Experience:
Minimum requirement of a Bachelors Degree in Microbiology, or closely related scientific discipline. A Degree in Microbiology is highly preferred.
3-5 years of recent and relevant experience
Previous experience with Disinfectant Efficacy study experience, strongly preferred.
Previous experience with swabbing and inoculating coupons with ATCC organisms.
Laboratory experience is preferred.
Pharmaceutical & FDA/GLP industry experience is preferred over academic laboratory experience.
Physical Requirements:
Requires long hours on standing at work bench or in a flow hood.
Large manufacturing site

Interview platform: phone followed by onsite
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Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 90564 while calling.
 
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(Engineer: Verbal Communication, Bachelor Degree In Computer Science, FDA, Pharma Experience in Marion, NC)
     
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