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Validation Engineer
Ref No.: 18-15044
Location: Marion, North Carolina
Position Type:Scientific
Start Date / End Date: 10/22/2018 to 01/21/2019
Job Requirements:
 
  • Conduct method development, method validation and method transfer for cleaning residual methods
  • Experience with cleaning agent HPLC method development and validation
  • Knowledge with swab coupon recovery studies
  • Excellent oral and written communication skills for participating in problem-solving teams and customer visits, as necessary.
  • Ability to work within given deadlines as required.
  • Know commonly used analytical equipment, its function and operation. Such equipment includes HPLC, UV-Vis and IR spectrophotometers, gas chromatograph, liquid chromatograph, incubator, oven, analytical scale, centrifuge, etc.
  • Maintain a chemically hygienic working environment.
 
Education:
 
  • Bachelor's degree in Life Sciences, or closely related scientific discipline.
  • Degree in Chemistry is highly preferred.
 
Experience:
 
  • Previous experience in writing and executing Method Validation protocols and reports.
  • 2-7 years of experience in Method Development in a GMP Pharmaceutical Industry Quality Control Laboratory a must.
  • Familiar with GMP regulated industry.
  • Expert with HPLC (UV/PDA/DAD detector)
  • Proficient in Empower software,
  • Knowledgeable in Microsoft Word and Excel
  • 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 analyses details and perform structured decision-making daily.
  • 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.
 
Manager Note:
 
  • Supplier spotlight call: TBD (update via FG chat) Analytical – person must have demonstrated proficiency in HPLC cleaning residual test method development and validation.
  • Ability to develop chromatography methods is required.
  • Ability to troubleshoot chromatography issues and recovery issues is required.
  • Candidates willing to relocate must do so on their own dime.
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