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Validation Engineer
Ref No.: 18-15045
Location: Marion, North Carolina
Position Type:Scientific (V)
Start Date / End Date: 10/22/2018 to 01/21/2019
Job 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.
Apply on-line for immediate consideration, please send your updated resume and contact info via
Contact: Asha Krishna
Email: asha@sunrisesys.com | 732-395-4591