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Validation Engineer
Ref No.: 18-13113
Location: Marion, North Carolina
Start Date: 10/04/2018
Description:

Test Method Validation: Chemist (Cleaning Residual Methods)
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.